AbbVie’s MAVIRETTM now reimbursed in Quebec

  • MAVIRET is now listed under the “Régie de l’assurance maladie du Québec” List of
  • MAVIRET is the first and only 8-week, pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to *1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease (CKD).

 

MONTREAL (Quebec), April 11, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed as a medication covered under Quebec’s public drug insurance plan. MAVIRET is a once-daily ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major HCV genotypes (GT1-6).2 It is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“Every day at my clinic I see the devastating effects of hepatitis C. The complications from this disease

can be fatal,” stresses Dr. Marc Poliquin, a gastroenterologist with the Clinique de médecine urbaine du Quartier latin and at Hôpital Verdun – CIUSSS du Centre-Sud-de-l’Île-de-Montréal. “Canada is looking to eliminate HCV and MAVIRET, a combination of glecaprevir and pibrentasvir, will help in achieving this objective. When I talk about MAVIRET to my patients, I can give them hope—even the most vulnerable patients. The treatment is short and effective, and has very few related side effects. We may possibly be able to eradicate this disease in Canada and, above all, avoid or reduce complications such as cirrhosis,

liver cancer and the need for liver transplantation.”

 

The reimbursement criteria for MAVIRET are as follows:3

  • As monotherapy for treatment of persons suffering from chronic hepatitis C who have never received an anti-HCV treatment.
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1, 2, 4, 5 or 6 who have experienced therapeutic failure with a treatment based on pegylated interferon (peg IFN) alfa- or based on sofosbuvir, but who have never been treated with either an NS3/4A protease inhibitor nor with an NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 3 without decompensated cirrhosis and who have experienced treatment failure with an association of ribavirin/pegylated interferon alfa or with an association of sofosbuvir/ribavirin, but have never been treated with either an NS3/4A protease inhibitor or NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1 without decompensated cirrhosis and who have experienced therapeutic failure with an NS3/4A protease inhibitor, but who have never been treated with an NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1 without decompensated cirrhosis and who have experienced therapeutic failure with an NS5A protein inhibitor, but who have never been treated with an NS3/4A protease

 

“For 15 years, the Centre Associatif Polyvalent d’Aide Hépatite C (CAPAHC), a hepatitis C support group, has been providing assistance to people living with HCV, while making Quebeckers aware of this insidious disease,” explains Laurence Mersilian, the centre’s general manager. “Today, thanks to treatments like MAVIRET, we can confidently tell our members and their loved ones that we are on the path towards eliminating this virus. However, we need to continue to work together on information, education and screening programs to meet World Health Organization targets.”

 

Approximately 300,000 Canadians are infected with chronic HCV.4 In Quebec, the number of reported cases is 39,136; however, the total number of people living with the disease is estimated to be 70,000. The prevalence is 0.74%. HCV is also the leading cause of liver transplantation in Canada, with an HCV– related death curve exceeding that of the human immunodeficiency virus (HIV) worldwide.5

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

About MAVIRET

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults across all major genotypes (GT1-6).6 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is taken once daily as three oral tablets.6

 

MAVIRET is an 8-week, pan-genotypic treatment that makes a virologic cure** possible in patients without cirrhosis who are new to treatment.*,1 These patients represent the majority of people infected with HCV. MAVIRET is also approved in patients with specific treatment challenges, including those with compensated cirrhosis, who are carriers of one of the major genotypes, and those who previously had limited treatment options, such as patients with severe CKD, post-liver and post-renal transplant recipients*** and those patients with genotype 3 HCV infection.6 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.6

 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and

Enanta Pharmaceuticals (NASDAQ: ENTA) to develop HCV protease inhibitors and therapeutic regimens that include protease inhibitors.

 

* Patients without cirrhosis and new to treatment with direct-acting antivirals (DDAs), (i.e., either treatment-naive or did not respond to previous interferon-based treatments (pegylated interferon [peg IFN] +/- ribavirin or sofosbuvirribavirin +/-peg IFN).

** Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4, -5 or -6 PRS (IFN or peg IFN, ribavirin and/or sofosbuvir)-treatment experienced. A 16-week treatment duration should be considered in transplant patients who are HCV GT-1 NS5A inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS- treatment experienced.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to

developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at

 

www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Muriel Haraoui AbbVie Canada 514-717-3764

muriel.haraoui@abbvie.com

 

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final: www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed April 2019. 3 Régie de l’assurance maladie du Québec. List of medications. Last updated April 11, 2019.

www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_04_11_en.pdf. Accessed April 2019.

4 The Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed March 2019.

5 Centre Associatif Polyvalent d’Aide Hépatite C. Hepatitis C: Frequently Asked Questions. www.capahc.com/hepatitis-c-faq/. Accessed April 2019.

6 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: November 28, 2018. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.p . Accessed April 2019.

AbbVie Announces New Formulary Listings for its Hepatitis C Treatment MAVIRET™

  • Alberta, Saskatchewan and their formularies

list MAVIRET on

 

  • MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

 

 

MONTREAL, QC, April 4, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that MAVIRET™ (glecaprevir/pibrentasvir tablets) is now reimbursed in Alberta, Saskatchewan and the Non-Insured Health Benefits (NIHB) Program. MAVIRET is a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).2 It is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“Hepatitis C is a public health issue that affects approximately 300,000 Canadians. Over time, chronic hepatitis C can lead to cirrhosis, liver cancer and death,” explains Dr. Samuel S. Lee, MD, Professor of Medicine and hepatologist at the University of Calgary. “In order to reach the elimination target set by the World Health Organization, we not only need concerted efforts by governments, health care

professionals and patient associations, but as well access to curative treatments like MAVIRET.”

 

In Alberta, MAVIRET is listed effective April 1, 2019, under Special Authorization on the AB Health Drug Benefit List for treatment-naïve or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria3:

  1. Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist (except on a case-by-case basis, in geographic areas where access to these specialties is not available); AND
  2. Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6; AND
  3. Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND
  4. Fibrosis stage of F0 or greater (Metavir scale or equivalent).

 

“Saskatchewan remains in the midst of a unique hepatitis C (HCV) epidemic, with many more young persons and women infected compared to the rest of Canada. Increased screening and testing is needed as many persons remain undiagnosed, and enhanced supports are required to link those diagnosed to treatment and care,” said Dr. Alexander Wong, MD, FRCPC, assistant professor of Infectious Diseases, University of Saskatchewan. “Having a new treatment option like MAVIRET, which can cure nearly all uncomplicated HCV-infected persons in only eight weeks, is a welcome and exciting addition to the drug formulary in Saskatchewan.”

 

In Saskatchewan, MAVIRET is listed effective April 1, 2019, on the Saskatchewan formulary as an Exception Drug Status (EDS) product, for treatment naïve and treatment experienced adult patients with chronic hepatitis C infection (regardless of fibrosis stage) according to the following criteria4:

  1. Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5 or 6; AND
  2. Laboratory confirmed quantitative HCV RNA value within the last six months; AND
  3. Treatment is prescribed by a hepatologist, gastroenterologist or an infectious disease specialist or other prescriber experienced in the treatment of hepatitis C as determined by the Drug

 

For the Non-Insured Health Benefits program (NIHB), MAVIRET is listed effective April 1, 2019, under Limited Use on the NIHB Drug Benefit List for treatment-naïve or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria:

  1. Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist (except on a case-by-case basis, in geographic areas where access to these specialties is not available); AND
  2. Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6; AND
  3. Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND
  4. Fibrosis stage of F0 or greater (Metavir scale or equivalent).

 

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

About MAVIRET™

MAVIRET™ is indicated in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).5 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.5

 

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*1 such patients comprising the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD), post-liver and -renal transplant recipients *** and those patients with genotype 3 infection.5 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.5

 

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

 

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].

**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT-1 to 6 treatment-naïve (TN) or GT-1, -2, -4, -5, -6 PRS- treatment experienced. A 16-week treatment duration should be considered in transplant patients who are GT-1 NS5A inhibitorexperienced (NS3/4A inhibitor-naïve) or GT-3 PRS- treatment experienced.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

Media:

Muriel Haraoui AbbVie Canada (514) 717-3764

muriel.haraoui@abbvie.com

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed April 2019. 3 Alberta Health. https://idbl.ab.bluecross.ca/idbl/lookupCoverageCriteria.do?productID=0000084466&priceListID=0013. Accessed April 2019.

4 Government of Saskatchewan. Saskatchewan Drug Plan. http://formulary.drugplan.ehealthsask.ca/PDFs/APPENDIXA.pdf. Accessed April 2019.

5 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: November 28, 2018. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf. Accessed April 2019.

British Columbia PharmaCare Lists AbbVie’s Hepatitis C Treatment MAVIRET™ on its Formulary

  • British Columbia PharmaCare lists MAVIRET on its formulary effective March 21, 2019
  • MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

 

MONTREAL, QC, March 22, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that MAVIRET™ (glecaprevir/pibrentasvir tablets) is now reimbursed in British Columbia. MAVIRET is a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).2 It is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

In British Columbia, MAVIRET is reimbursed for the treatment of treatment-naïve or treatment- experienced adult patients with chronic hepatitis C including all genotypes 1-6. The listing became effective on March 21, 2019.3

 

“Hepatitis C represents a crisis in Canada and around the world. But it doesn’t have to be the case for much longer. We now have the ability to effectively screen, diagnose, treat and cure people living with this devastating disease,” explains Dr. Brian Conway, Infectious Diseases Specialist and medical director of the Vancouver Infectious Disease Centre. “When treatment is initiated earlier, with options such as MAVIRET, we have the potential to reduce transmission rates, the risk of death from associated conditions such as liver cancer and the long-term management costs of this disease. MAVIRET is an

important tool to help us achieve the World Health Organization objective of eliminating HCV as a public health concern in Canada by 2030.”

 

Approximately 300,000 Canadians are infected with hepatitis C.4 British Columbia has the highest rate of hepatitis C in Canada. There are an estimated 80,000 people living with the virus in the province and about 2,500 new cases of hepatitis C are identified each year.5

 

“The vision of our organization is for British Columbia to be free from new hepatitis C cases, while offering the best possible care and support for those already living with this disease,” said Daryl Luster, President of the Pacific Hepatitis C Network (PHCN). “Today, I am optimistic that this is well within our reach because we already have the right treatments that offer high cures. By collaborating together, we will be able to move towards the elimination of the hepatitis C virus in British Columbia and Canada.”

 

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

About MAVIRET™

MAVIRET™ is indicated in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).6 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.6

 

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*1 such patients comprising the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD), post-liver and -renal transplant recipients *** and those patients with genotype 3 infection.6 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.6

 

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

 

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].

**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT-1 to 6 treatment-naïve (TN) or GT-1, -2, -4, -5, -6 PRS- treatment experienced. A 16-week treatment duration should be considered in transplant patients who are GT-1 NS5A inhibitorexperienced (NS3/4A inhibitor-naïve) or GT-3 PRS- treatment experienced.

 

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Muriel Haraoui AbbVie Canada (514) 717-3764

muriel.haraoui@abbvie.com

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed March 2019. 3 British Columbia Pharmacare. https://www2.gov.bc.ca/gov/content/health/practitioner-professional-

resources/pharmacare/prescribers/limited-coverage-drug-program/limited-coverage-drugs-glecaprevir-pibrentasvir. Accessed March 2019.

4 The Canadian Liver Foundation. https://www.liver.ca/how-you-help/advocate/. Accessed March 2019. 5 British Columbia Centre for Excellence in HIV/AIDS. Hepatitis C (HCV) Fact sheet. http://www.cfenet.ubc.ca/sites/default/files/uploads/HCV%20Fact%20Sheet.pdf. Accessed March 2019.

6 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: November 28, 2018. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf. Accessed March 2019.

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for its hepatitis C treatment MAVIRET™

• Ontario will be the first province to reimburse MAVIRET as of February 28, 2019
• MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
• MAVIRET previously received positive reimbursement recommendations from the CADTH Canadian Drug Expert Committee (CDEC)2 in January 2018 and the Institut national d’excellence en santé et services sociaux (INESSS) in February 2018
• MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, QC, February 21, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6)2. MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada.

Following the positive conclusion with the pCPA, Ontario will be the first province to reimburse MAVIRET on its public formulary as of February 28, 2019. As listed on the Ontario Drug Benefit (ODB)3 Formulary as a Limited Use product, MAVIRET will be covered for treatment-naïve and treatment- experienced adult patients with chronic hepatitis C infection (regardless of fibrosis stage) 3:
• Laboratory confirmed hepatitis C genotype 1,2,3,4,5,6
• HCV RNA value within the last six months
***Prescription by a hepatologist, gastroenterologist or an infectious disease specialist (or other physician experienced in treating hepatitis C).

“After more than 20 years of treating hepatitis C, I am hopeful that soon we will successfully eliminate this virus. But in order to reach this goal in Canada and across the world, we need to work together to test, diagnose and bring these high curative treatments to every individual, regardless of their genotype, fibrosis stage and background,” explains Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist,
Director of the Toronto Liver Centre. “As a hepatologist, MAVIRET offers me the opportunity to put my patients on an effective, short duration therapy that has a proven track record.”

Approximately 300,000 Canadians are infected with hepatitis C.4 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 per cent within 20 years5 of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)-based treatment option.6

“The Canadian Liver Foundation is committed to seeing Canada meet the target set by the World Health Organization’s Global Strategy on Viral Hepatitis. And that target is to eliminate hepatitis C by 2030. It is within our reach, but all our elimination efforts require support, plans and concrete actions at the local level to combat the increasing burden of HCV infection and the associated stigma,” says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. “To be successful, we need a comprehensive screening strategy based on risk factors, plus a one-time test for all Canadians born 1945 – 19757, as well as adapted linkage to care to allow access to all available treatment options for all Canadians.”

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

“AbbVie is committed to the World Health Organization’s targets and looks forward to working with governments, health care professionals and patient associations in their concerted efforts to achieve HCV elimination in Canada,” explains Stéphane Lassignardie, General Manager, AbbVie Canada.
“MAVIRET brings value in order to achieve elimination and all Canadians should have access to innovative and curative therapies.”

About MAVIRET™
MAVIRET™ is approved in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).8 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.8

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*1 such patients comprising the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) and those with genotype 3 infection.8 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.8
Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at

www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

###

Media:
Muriel Haraoui AbbVie Canada (514) 717-3764
muriel.haraoui@abbvie.com

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.
2 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed February 2019.
3 Ontario Drug Benefit Formulary/Comparative Drug Index Edition 43. Summary of Changes – February 2019. Effective February 28, 2019. http://www.health.gov.on.ca/en/pro/programs/drugs/formulary43/summary_edition43_20190220.pdf. Accessed
February 2019.
4 The Canadian Liver Foundation. https://www.liver.ca/how-you-help/advocate/. Accessed February 2019. 5 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 2019.
6 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10. 7 The Canadian Liver Foundation, press release: https://www.newswire.ca/news-releases/not-getting-the-message-too-many- canadians-born-between-1945-1975-unaware-of-their-increased-risk-of-undiagnosed-hepatitis-c-587783871.html. Accessed February 2019.
8 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf. Accessed February 2019.

AbbVie’s HUMIRA® (Adalimumab) Approved by Health Canada to Treat Pediatric Patients with Chronic Non-infectious Anterior Uveitis

  • The approval marks HUMIRA as the only approved biologic treatment option in Canada for pediatric patients from two years of age with chronic non-infectious anterior uveitis who have had inadequate response to conventional therapy
  • The approval is based on results from SYCAMORE, an investigator-initiated clinical trial, which showed that HUMIRA combined with methotrexate significantly delayed the time to treatment failure compared to methotrexate plus placebo in children with active JIA-associated uveitis1
  • Juvenile idiopathic arthritis (JIA) is the most common systemic disorder associated with non- infectious uveitis in children, accounting for more than 75 percent of cases of pediatric anterior uveitis2

 

MONTREAL, QC, February 20, 2019 — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved HUMIRA® (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. HUMIRA is now the only approved biologic treatment option for chronic non-infectious anterior uveitis in children aged two years and older in Canada.

 

“This approval marks an important milestone for pediatric uveitis patients and their caregivers who, up until this point, had no biologic treatment options available to them,” said Stéphane Lassignardie, General Manager of AbbVie Canada. “This label expansion for HUMIRA further demonstrates AbbVie’s dedication to addressing the unmet medical needs for both adult and pediatric patients living with serious immune-mediated inflammatory diseases.”

 

Uveitis is an inflammation of the uvea, which includes the iris, choroid and the ciliary body in the eye.3 If left untreated, it can lead to vision loss, including cataracts, glaucoma and cystoid macular edema (CME).4,5 Severe vision loss has been estimated to occur in 25 to 30 percent of pediatric uveitis cases, making early diagnosis and treatment essential to preserve vision in children with the disease.4,6 JIA is the most common systemic disorder associated with uveitis in children accounting for more than 75 percent of cases of pediatric anterior uveitis.2

 

“For many children, the diagnosis of uveitis carries a significant burden in terms of number of visits to the hospital, threat to the patient’s vision and anxiety for the whole family,” explained Dr. Eric Fortin, ophthalmologist at the University of Montreal Ophthalmology Center. “Having this approval for the indication of pediatric uveitis will hopefully lead to easier access to HUMIRA for those patients who need it. That is something that is very important both to me and my patients.”

 

 

 

“Pediatric uveitis is a debilitating and potentially blinding condition, which poses overwhelming challenges to children and their families,” said Christina Pelizon, Medical Director, AbbVie Canada. “The SYCAMORE study showed that HUMIRA in combination with methotrexate significantly delayed the time to treatment failure compared with methotrexate plus placebo. These results demonstrate HUMIRA has the potential to help many children who have failed standard treatments preserve their eyesight from the ocular complications associated with chronic non-infectious anterior uveitis.”

 

The SYCAMORE clinical trial is a randomized controlled study of the clinical efficacy and safety of HUMIRA combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA- associated uveitis. It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The Independent Data Safety and Monitoring Committee (IDSMC) recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis because it showed that HUMIRA combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure, defined according to several criteria, including multiple components of intraocular inflammation, than placebo.1

 

About the SYCAMORE Trial1

The SYCAMORE clinical trial was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The study was supported by grants from the National Institute for Health Research Health Technology Assessment Programme and Arthritis Research UK. In this multicenter, double-masked, randomized, placebo- controlled trial, researchers assessed the efficacy and safety of HUMIRA in children and adolescents two years of age and older who had active JIA-associated uveitis noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.

 

Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either HUMIRA (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every two weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. Including a 6 months off-study drug period, they were followed for up to two years after randomization. The primary endpoint was the time to treatment failure, defined as meeting at least one of the following criteria: multiple components of intraocular inflammation, worsening or development of ocular comorbidities, use of concomitant medications that were not allowed or that did not follow pre-specified criteria, and suspension of treatment for an extended period of time.

 

Study results showed that the addition of HUMIRA to methotrexate significantly delayed the time to treatment failure as compared with placebo, and the pre-specified stopping criteria were met after the enrollment of 90 of 114 patients. Researchers observed 16 treatment failures in 60 patients (27 percent) in the HUMIRA group versus 18 treatment failures in 30 patients (60 percent) in the placebo group (hazard ratio, 0.25; 99.9 percent confidence interval [CI], 0.08 to 0.79; P<0.0001 [the pre-specified stopping boundary]).

 

 

About HUMIRA

 

 

 

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

 

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 15 indications globally (11 in Canada), including more than 71 clinical trials with more than 23,000 patients. HUMIRA is approved in 90 countries and used by more than one million patients worldwide.

 

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects.7 Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph1available at www.abbvie.ca.

 

Important Safety Information

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

 

 

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph at www.abbvie.ca

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at abbvie.ca and abbvie.com. Follow @abbviecanada and @abbvie on Twitter, or view careers on our Facebook or LinkedIn page.

 

 

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Media:

Julie Lepsetz AbbVie Canada (514) 832-7268

julie.lepsetz@abbvie.com

 

 

 

References:

 

1 Ramanan A.V., Dick, A.D., et.al. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017;376:1637-46.

2 Palejwala, N.V., Yeh, S. & Angeles-Han, S.T. Current Perspectives on Ophtalmic Manifestations of Childhood Rheumatic Diseases. Curr Rheumatol Rep (2013) 15: 341. doi:10.1007/s11926-013-0341-3.

3 Clarke SL, Sen ES, Ramanan. Juvenile idiopathic arthritis-associated uveitis. Pediatr Rheumatol Online 2016. 14:27. doi: 10.1186/s12969-016-0088-2.

4 Cunningham ET Jr. Uveitis in children. Occular Immunology and Inflammation. 2009. 8:4, 251-261. DOI: 10.1076/ocii.8.4.251.6459.

5 Smith J.A., Mackensen F., Sen H.N., et al. Epidemiology and course of disease in childhood uveitis. Ophthalmology. 2009 Aug;116(8):1544-1551.

 

 

 

 

 

6 Bhat, P.V., MD; Goldstein, D.A., MD. Pediatric Anterior Uveitis. Available at: https://www.aao.org/pediatric- center-detail/pediatric-anterior-uveitis. Accessed February 6, 2019.

7 HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. Last updated January 23, 2019.

Health Canada Approves Label Update for AbbVie’s HUMIRA® (adalimumab) Supporting Potential For Use During Breastfeeding and Use During Pregnancy if Clearly Needed

  • Updated label provides guidance that HUMIRA use can be considered while breastfeeding and should only be used during pregnancy if clearly needed1
  • Approval is supported by postmarketing data, a prospective cohort registry analysis designed to monitor and evaluate the exposure to medication during pregnancy, as well as literature regarding lactation1

 

MONTREAL, QC, October 15, 2018 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved a label update for HUMIRA® (adalimumab) to include clinical and postmarketing safety data surrounding pregnancy and breastfeeding. This label update includes guidance that HUMIRA use can be considered while breastfeeding and should only be used during pregnancy if clearly needed.1

 

“While Abbvie continues to exercise appropriate due caution regarding the safety of its products, the recent label change for HUMIRA is reassuring for women living with inflammatory bowel disease (IBD), particularly because IBD most commonly affects individuals in their peak reproductive years,” said Dr. Cynthia Seow, Associate Professor, Division of Gastroenterology and Hepatology, University of Calgary. “While HUMIRA should be used during pregnancy only if clearly needed, this label update cites data demonstrating a lack of pattern of major birth defects with the use of HUMIRA during pregnancy, and a statement on the relative safety of HUMIRA use whilst breastfeeding.”

 

“This label update provides important, clinically meaningful information allowing women and their healthcare professionals to better understand the safety of HUMIRA during pregnancy and

breastfeeding, and to make an informed treatment decision,” said Christina Pelizon, Medical Director, AbbVie Canada. “Understanding how immune-mediated diseases impact patients at all stages of life drives the way we conduct research and generate evidence to advance the field of immunology.”

 

The Health Canada label update is based on final data from a prospective cohort pregnancy exposure registry conducted by OTIS (Organization of Teratology Information Specialists) / MotherToBaby, the leading group of maternal health experts in evaluation of drugs during pregnancy in North America, as well as literature review regarding lactation.

 

 

 

 

 

 

 

 

The registry, conducted in the U.S. and Canada between 2004 and 2016, compared the risk of major birth defects in live-born infants in 69 women with rheumatoid arthritis (RA) and 152 women with Crohn’s disease (CD) treated with adalimumab at least during the first trimester with 74 women with RA and 32 women with CD not treated with adalimumab during pregnancy. The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively.

 

The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and the risk for major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non- randomized design.

 

Adalimumab may cross the placenta into the serum of infants born to women treated with HUMIRA during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following the mother’s last HUMIRA injection during pregnancy.

 

Limited information from case reports in the published literature indicates the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. Published data suggest that the systemic exposure of adalimumab to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. However, the effects of local exposure in the gastrointestinal tract are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for adalimumab and any potential adverse effects on the breastfed child from adalimumab or from the underlying maternal condition.

 

 

About HUMIRA

 

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

 

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 14 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

 

 

 

 

 

 

 

 

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects.1 Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph1available at www.abbvie.ca.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at abbvie.ca and abbvie.com. Follow @abbviecanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

Important Safety Information

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

 

 

 

 

 

 

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph at www.abbvie.ca

 

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Media:

Julie Lepsetz AbbVie Canada (514) 832-7268

julie.lepsetz@abbvie.com

 

 

 

References:

1 HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. Last updated August 28, 2018.

AbbVie Receives Health Canada Approval of ORILISSATM (elagolix) for the Treatment of Moderate to Severe Pain Associated with Endometriosis

  • Endometriosis affects up to one in 10 women of reproductive age in 1
  • 7 out of 10 women being managed for endometriosis have unresolved pain throughout the 2
  • The approval of ORILISSA is supported by data from two replicate Phase 3 studies, which evaluated nearly 1,700 women.
  • In clinical trials, ORILISSA™demonstrated sustained relief over 12 months across the two most common types of pain: dysmenorrhea and non-menstrual pelvic 3

 

 

Montreal, QC, October 5, 2018 –AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that Health Canada approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of moderate to severe pain associated with endometriosis.3

 

ORILISSA (elagolix) is a novel, orally administered, highly potent, short-acting, selective, non-peptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulation hormone (FSH) levels, leading to decreased blood levels of the ovarian sex hormones, estradiol and progesterone. LH and FSH suppression begins within hours of administration and is readily reversible upon discontinuation of ORILISSA.3

 

“Endometriosis causes a significant impact on the quality of life of women because of the debilitating and incapacitating pain. Women living with endometriosis can be sidelined by this disease,” says Dr. Nicholas A. Leyland, BASc, MD, MHCM, FRCSC, Chair of the Department of Obstetrics and Gynaecology, McMaster University. “Since there is no cure, the goal of treatment is to alleviate the symptoms and improve a woman’s quality of life. With ORILISSA, we are now able to offer our patients an additional new option that can help them resume living their lives.”

 

Endometriosis causes chronic pelvic pain and is sometimes associated with infertility. It affects up to one in 10 women of reproductive age in Canada.1 Furthermore, 7 out of 10 women being managed for endometriosis have unresolved pain throughout the month. 2

 

“Endometriosis is a complex and incurable disease. This is why early diagnosis is extremely important. Currently, on average, it takes seven to nine years of complaining about symptoms to medical professionals to receive a diagnosis of endometriosis. Therefore, earlier diagnosis and treatment can help mitigate years of unnecessary suffering,” explains Philippa Bridge-Cook, Ph.D., The Endometriosis Network Canada. “In addition, patients coping with symptoms without a diagnosis can sometimes face dismissal of their symptoms from friends, family, and even medical professionals. This can lead to feelings of isolation, anxiety, and depression.”

 

 

The approval of ORILISSA is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated ORILISSA significantly reduced the two most common types of endometriosis pain: dysmenorrhea and non-menstrual pelvic pain. A higher proportion of women treated with ORILISSA 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and non-menstrual pelvic pain compared to placebo in a dose- dependent manner at month three. Women were defined as responders if they experienced a reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain. 3

 

Both ORILISSA treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain at month six. Women in the Phase 3 studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS) and women taking ORILISSA 150 mg once daily and 200 mg twice daily reported a statistically (p <0.001) significant reduction from baseline in NRS scores compared to placebo at month three. Clinical trial data also demonstrated women taking ORILISSA 200 mg twice daily showed statistically significant greater reduction in pain during sexual intercourse from baseline to month three compared to placebo. The most frequent (≥10%) adverse reactions reported in clinical trials with ORILISSA (elagolix) were hot flush, headache and nausea. 3

 

The recommended duration of use for ORILISSA is up to 12months for the 150 mg once daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment.3

 

“The approval of ORILISSA demonstrates AbbVie’s continued commitment to women living with endometriosis. We are proud of our heritage in women’s health and strive to fill the unmet medical need by providing a safe and efficacious treatment,” says Stéphane Lassignardie, General Manager of AbbVie Canada.

 

ORILISSA is expected to be available in Canadian retail pharmacies in early November 2018.

 

About AbbVie Care

Canadian women prescribed ORILISSA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at

 

 

www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

About Neurocrine Biosciences, Inc.

Neurocrine Biosciences, a San Diego based biopharmaceutical company, is focused on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA® (valbenazine), the first FDA approved product indicated for the treatment of adults with tardive dyskinesia, a movement disorder. Discovered and developed through Phase II clinical trials by Neurocrine, ORILISSA™ (elagolix), the first FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain in over a decade, is marketed by AbbVie as part of a collaboration to develop and commercialize elagolix for women’s health. Neurocrine’s clinical development programs include opicapone as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson’s disease patients, elagolix for uterine fibroids with AbbVie, valbenazine for the treatment of Tourette syndrome, and NBI-74788 for the treatment of congenital adrenal hyperplasia (CAH). For more information and the latest updates from Neurocrine, please visit www.neurocrine.com.

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

1YourPeriod.ca – https://www.yourperiod.ca/endometriosis/what-is-endometriosis/

2De Graaff AA, D’Hooghe TM, Dunselman GAJ, Dirksen CD, Hummelshoj L, WERF EndoCost Consortium, Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013;28(10):2677-2685.

3Orilissa Product Monograph, AbbVie Corporation, October 5, 2018.

Health Literacy Still an Issue in Canada

  • 60 per cent of Canadian adults and 88 per cent of seniors are not health literate
  • ABC Life Literacy launches nine new resources as part of its ABC Health Matters program
  • Low literacy is associated with poor health outcomes

 

(Toronto, ON – September 27, 2018) October is Health Literacy Month, a time to increase understanding of health information and for Canadians to take charge of their health. According to the Public Health Agency of Canada, 60 per cent of Canadian adults and 88 per cent of seniors are not health literate.

 

In recognition of Health Literacy Month, ABC Life Literacy Canada has developed nine new resources for patients and health care providers as part of the ABC Health Matters program. Good health literacy means being able to access, understand, evaluate, communicate and use information related to your health and the health of others to make appropriate health decisions.

 

The ABC Health Matters program was created to help Canadians to manage their health more effectively by increasing their confidence when talking about and making decisions regarding health issues. ABC Life Literacy developed a workbook-led workshop, delivered at community learning and health care centres across Ontario. Through the program, adults develop a deeper understanding of how to advocate for their own health as well as the health of their family and gain a better understanding of how to access health care.

 

“It would be hard to find something more personal to someone than their health,” said ABC Executive Director Mack Rogers. “It can be frustrating and sometimes frightening to feel as if you don’t have control over your own health which is why we created the ABC Health Matters program. The program empowers Canadians to manage their health more effectively and increases their confidence in discussing their health issues with health care providers.”

 

This year, additional resources were developed for the ABC Health Matters program to help Canadians take charge of their health during Health Literacy Month. New resources available at ABCHealthMatters.ca include:

 

  • Health Passport – pocket-sized guide for patients when speaking with health care providers
  • Medical History Card – a place to keep track of medical history to keep with you
  • Tips for Your Doctor Visit – sample questions for patients when speaking with their doctor
  • You and Your Pharmacist – details of support available from your local pharmacist
  • Your Rights as a Patient – your rights and responsibilities as a patient
  • Caring for Loved ones – tips for caregivers for how to support and advocate for someone under your care

 

Tools were also created for health care providers to support communication with patients with low literacy as well as posters for placement in waiting rooms and the pharmacy with questions and information for patients.

 

“AbbVie is proud to be a founding member of the ABC Health Matters program,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “We believe that every Canadian should be an advocate for their own health. When you understand the health care system, you are better equipped to navigate its intricacies and access the right services for yourself and your family. This will result in improved health outcomes for all.”

 

 

Health Literacy Month is a great opportunity for Canadians to commit to increasing their health literacy and the new ABC Health Matters resources will give them the tools to do just that. ABC Life Literacy will also launch an awareness campaign leading up to Health Literacy Month to heighten awareness and access to the free ABC Health Matters tools and resources.

 

ABC Health Matters was created with the support of AbbVie Corporation. Two workbooks that can be used for workshop delivery or for learning at home as well as the new resources are available for free download at ABCHealthMatters.ca.

 

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About ABC Life Literacy Canada

ABC Life Literacy Canada is a non-profit organization that inspires Canadians to increase their literacy and essential skills. We mobilize business, government and communities to support lifelong learning and achieve our goals through leadership in programs, communications and partnerships. We envision a Canada where everyone has the skills they need to live a fully engaged life. For the latest news and information on adult literacy please visit www.abclifeliteracy.ca, follow us on Twitter or join our Facebook page.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on

our Facebook or LinkedIn page.

 

 

For more information, please contact:

Ana Oliveira

Director of Marketing, Communications and Development ABC Life Literacy Canada

416-218-0010 ext. 121

aoliveira@abclifeliteracy.ca

 

Muriel Haraoui Communications Manager AbbVie Canada

514-717-3764

muriel.haraoui@abbvie.com

ABBVIE RECEIVES APPROVAL FROM HEALTH CANADA FOR THE COMBINATION OF VENCLEXTA® WITH RITUXIMAB AS A TREATMENT FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

  • In the MURANO Phase 3 clinical trial, the VENCLEXTA® (venetoclax) plus rituximab combination showed a significant improvement in progression-free survival (PFS, the time on treatment without disease progression or death) for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) patients,
  • The combination of VENCLEXTA plus rituximab reduced the risk of disease progression or death by 81 percent when compared to a standard of care chemoimmunotherapy regimen, bendamustine plus rituximab.i
  • Patients receiving VENCLEXTA plus rituximab achieved a high overall response rate (ORR) of 92 i
  • With this approval, VENCLEXTA plus rituximab is the first chemotherapy-free combination with a 24-month treatment duration for
  • Approximately 2,400 cases of chronic lymphocytic leukemia (CLL) are diagnosed every year in Canadii

 

Montreal, QC, September 25, 2018 –AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced Health Canada has issued a Notice of Compliance for VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.i

 

“Having another effective therapy for relapsed/refractory CLL is a great benefit to patients. It is also valuable to have this new therapy be of fixed duration because most patients prefer not to have to

remain on therapy indefinitely” explains Dr. Carolyn Owen, MD, MDres(UK), FRCPC, a Hematologist and associate professor at the University of Calgary. “With venetoclax plus rituximab, I can now offer my patients an effective treatment with a clear end-date, allowing patients to plan for the future and enjoy time off therapy.”

 

The approval is based on the MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival (PFS, the time on treatment without disease progression or death) for relapsed/refractory (R/R) CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen.i

 

“Lymphoma Canada is pleased with the approval of VENCLEXTA in combination with rituximab for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is imperative to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Elizabeth Lye, Scientific Advisor, Lymphoma Canada.

 

Clinical trial patients who received VENCLEXTA plus rituximab achieved an overall response rate (ORR) of 92 percent and those who received the bendamustine plus rituximab regimen achieved an ORR of

 

72 percent.i The most common adverse reactions (ARs), greater than or equal to 20 percent, with a 5 percent higher frequency reported with VENCLEXTA in combination with rituximab were neutropenia, diarrhea and upper respiratory tract infection.i

 

“When my CLL relapsed for the second time, I was fortunate to have access to VENCLEXTA in

combination with rituximab,” explains Mark Silverstein of Aurora, ON. “Today, I am able to enjoy an improved quality of life, and do what brings a great deal of meaning to my life: to help others navigate through their cancer journey with confidence and dignity by encouraging them to advocate for themselves within the health care system, reflect on the potential benefits in understanding their cancer and treatment landscape, to assist in managing the emotional and spiritual effects of a diagnosis, and finally to help them find what is meaningful in their own lives.”

 

In Canada, CLL accounts for approximately 2,400 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.ii The goal of treatment is to delay progression of the disease and improve quality of life.

 

“VENCLEXTA plus rituximab is the first chemotherapy-free combination in CLL that allows patients a 24- month treatment duration,” says Stéphane Lassignardie, General Manager of Abbvie Canada. “The approval of this regimen will bring a much needed treatment option to Canadians living with CLL.”

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases.

 

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

 

About the MURANO Study

A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized (1:1) MURANO study (NCT02005471). The study was designed to evaluate the efficacy and safety of VENCLEXTA in combination with rituximab (194 patients) compared with bendamustine in combination with rituximab (195 patients). The median age of patients in the trial was 65 years (range 22-85).i

 

About AbbVie Care

Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

i VENCLEXTA product monograph, AbbVie Corporation, September 21, 2018

ii Canadian Cancer Statistics, 2015 http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic- lymphocytic-cll/statistics/?region=on

Crohn’s and Colitis Canada Selects 10 AbbVie IBD Scholarship Recipients

TORONTOAug. 14, 2018 /CNW/ – Crohn’s and Colitis Canada has awarded 10 scholarships to post-secondary students through the AbbVie IBD Scholarship Program. The students, hailing from universities across the country, all strive to sustain an optimal level of wellness while living with Crohn’s disease or ulcerative colitis and inspire others to do the same.

Canada has one of the highest rates of inflammatory bowel disease (IBD) in the world as nearly a quarter of a million people live with either Crohn’s disease or ulcerative colitis, which are the two main forms of IBD. The autoimmune diseases cause the body to attack healthy tissue, leading to inflammation of all or part of the gastrointestinal tract. Common symptoms include severe abdominal pain, nausea, fatigue, internal bleeding, and the unpredictable and urgent need to use the washroom.

“People are often diagnosed with Crohn’s disease or ulcerative colitis in their late teens or early 20s, which can make the already challenging task of completing post-secondary education all the more stressful,” said Mina Mawani, President and CEO, Crohn’s and Colitis Canada. “Our scholarship recipients demonstrate their strength and resilience in overcoming these challenges on a daily basis. Crohn’s and Colitis Canada is delighted to support our recipients and proud that they continue to support others living with these chronic diseases by being actively involved in their communities, all while striving towards their academic goals.”

Since 2012, the AbbVie IBD Scholarship Program has supported nearly 70 Canadian students in navigating post-secondary education while living with Crohn’s or colitis by awarding scholarships that total in excess of $345,000. Scholarships of up to $5,000 are contributed towards each student’s tuition.

“We are very proud of the impact that this longstanding program is having on the lives of post-secondary students,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “Attending school while dealing with the stress of managing Crohn’s or colitis is a real challenge and it is critical to support and encourage these students.”

Crohn’s and Colitis Canada congratulates the following 2018 AbbVie IBD Scholarship recipients:

  • Naji Balche – Western University
  • Kristin Bridges – Queen’s University
  • Ashley Clark – University of Victoria
  • Sarah Jane Downton – Acadia University
  • Emma Moore – University of Prince Edward Island
  • Navjit Moore – University of British Columbia
  • Kayleigh Pink – University of Ottawa
  • Evan Rootenberg – Ryerson University
  • Natalie Sousa – University of British Columbia
  • Claudia Tersigni – University of Toronto

To learn more about the 2018 AbbVie IBD Scholarship recipients, please visit ibdscholarship.ca.

About Crohn’s and Colitis Canada
Crohn’s and Colitis Canada is on a relentless journey to find cures for Crohn’s disease and ulcerative colitis and improve the lives of children and adults affected by these chronic diseases. We are the country’s largest volunteer-based organization with this mission and one of the top two health charity funders of Crohn’s and colitis research in the world, investing over $115 million in research to date. We are transforming the lives of people affected by Crohn’s and colitis through research, patient programs, advocacy, and awareness. For more information, please visit crohnsandcolitis.ca and follow us @getgutsycanada on TwitterFacebook, and Instagram.

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca or follow us on Twitter at @abbviecanada.

SOURCE Crohn’s and Colitis Canada

For further information: or to arrange interviews, please contact: Derek Holota, Smithcom Ltd., 647-473-7723, derek.holota@smithcom.ca; Stacey Sheehan, Marketing and Communications Coordinator, Crohn’s and Colitis Canada, 416-920-5035 ext. 243, ssheehan@crohnsandcolitis.ca