AbbVie’s Suzanne Campbell recognized by peers

Montreal, Quebec, October 23, 2019 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced today that Suzanne Campbell, Senior Brand Manager, Dermatology was inducted into the Canadian Healthcare Marketing Hall of Fame.

 

The Canadian Healthcare Marketing Hall of Fame awards were established to honor healthcare marketers who have contributed to the industry avocation and are an inspiration to others.

 

Suzanne Campbell credits her success to the team around her, which encompasses a motto that has governed her career—Together Everyone Achieves More (TEAM). “I constantly see that any idea or strategy gets so much better when you have the brain power of multiple colleagues and multiple perspectives,” said Campbell. “And that collaboration makes any project more robust.”

 

Suzanne was recognized for her work in hidradentis suppurativa (HS). HS is a painful, chronic, systemic, immune-mediated skin disease which affects between 1 to 3% of the global population however the diagnosis is often delayed or the condition is misdiagnosed with the true prevalence unknown.1 HS is known to produce lesions in the skin that are inflamed (swollen), recurrent and chronic (lasting for an extended period of time). HS can have both a psychological and physical impact.

 

“When I started meeting people with HS, their patient journey, which had been a very negative one in the healthcare system, became my passion project.”

 

Stéphane Lassignardie, President, AbbVie Canada added: “We are very proud of Suzanne for this important acknowledgement. It is testament of our industry recognizing the importance of finding solutions for patients’ where there are no options and real medical need for solutions.”

 

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:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

 

 

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1 The Canadian Hidradenitis Suppurativa Foundation – www.hs-foundationcanada.org

VENCLEXTA®, a treatment for chronic lymphocytic leukemia (CLL), now reimbursed across Western Canada

Montreal, QC, September 25, 2019 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced today that Alberta, Manitoba, British Columbia and Saskatchewan are listing VENCLEXTA® (venetoclax) on their public formularies. VENCLEXTA monotherapy is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and for whom there are no other available treatment options. VENCLEXTA is an oral, once-daily medicine.

 

“People living with chronic lymphocytic leukemia in Western Canada finally have access to Venclexta, which is great news considering the nature of this disease. When faced with CLL, which can be recurrent, it is important to offer physicians and their patients highly effective options to tackle this illness,” explains Elizabeth Lye, Director of Research & Programs at Lymphoma Canada. “At Lymphoma Canada, we hope that soon all Canadians will have access to this treatment.”

 

VENCLEXTA is listed under the Alberta Health Services, Outpatient Cancer Drug Benefit Programi, as a Part 3 benefit in Manitoba Pharmacare’s Home Oncology Drug Programii, by the British Columbia Cancer Lymphoma Tumour Groupiii and on the formulary of the Saskatchewan Cancer Agencyiv. All four provinces reimburse VENCLEXTA monotherapy for CLL patients who have received at least one prior therapy and who have failed a B-Cell receptor inhibitor (BCRi), with specific criteria.

 

For further information regarding specific provincial criteria consult the links below:

 

“As a clinician, I need to have several treatment options available for my patients to effectively and successfully treat their CLL. It is great news that venetoclax is now reimbursed for Western Canadians,” says Dr. Carolyn Owen, MD, MDres(UK), FRCPC, Associate Professor, Division of Hematology and Hematological Malignancies, Foothills Medical Centre. “Venetoclax is an innovative molecule that selectively inhibits the BCL-2 protein, which is responsible for helping cancer cells survive in the blood.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodv, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.vi

 

“When my physician told me I had CLL, I had no idea what this meant for my life expectancy. I am a husband, father and grandfather and I want to be around for my family as long as possible,” explains

 

Dale Jordan of Calgary, Alberta. “After discussing my options with my physician, he recommended VENCLEXTA. I am fortunate to live in a province where people can now access this medication.”

 

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

 

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. 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 Alberta Health Services. https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf. Accessed September 2019.

ii Manitoba Pharmacare. Manitoba Drug Benefits and Interchangeability Formulary Amendments. Bulletin #105. Effective August 22, 2019. https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin105.pdf. Accessed

September 2019.

iii BC Cancer. Provincial Systemic Therapy Program. September 2019. http://www.bccancer.bc.ca/systemic- therapy-site/Documents/2019%20ST%20Updates/ST%20Update_Sep%202019.pdf. Accessed September 2019. iv Saskatchewan Cancer Agency Drug Formulary. September 3, 2019. http://www.saskcancer.ca/Drug%20Formulary%2009-2013. Accessed September 2019.

v Lymphoma Canada. Chronic lymphocytic leukemia. Available at www.lymphoma.ca/lymphoma/lymphoma- 101/types-lymphoma/cll. Accessed September 2019.

vi Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed September 2019.

AbbVie is committed to the elimination of hepatitis C in Canada by 2030

  • Everyone has a part to play in making hepatitis C (HCV) elimination the next public health success
  • Partnerships are essential to solving some of the most pressing

 

MONTREAL (Quebec), July 25, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, supports a wide range of efforts to help elevate and prioritize hepatitis C (HCV) elimination because achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with healthcare professionals, governments and community organizations to remove barriers to care and to help simplify treatment options, especially for the Priority populations, which include people who inject or use drugs, as well as immigrants and newcomers to Canada.1

 

“HCV elimination starts with demonstrating our commitment to the World Health Organization 2030 goal,” explains Stéphane Lassignardie, General Manager, AbbVie Canada. “Through partnerships with stakeholders, we are working to find sustainable solutions that allow more patients to be screened, linked to care, and treated in a shorter period of time. We have engaged with governments across Canada to lower the price of hepatitis C treatments so that every patient cured accelerates the path to elimination. This is because we have a shared commitment and by working together, we can eliminate this disease.”

 

In Canada, an estimated 250,000 people are living with chronic hepatitis C but as many as 44% are not aware that they have it.1 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.2 Of the people who inject drugs, 66% have past or current HCV infection. 1

 

Cool Aid Community Health Centre based in Victoria, British Columbia, provides integrated primary

health care services within a multidisciplinary team to treat illness and promote wellness. “Because HCV disproportionately affects marginalized populations in Canada, our nurse-led model for the treatment of HCV focuses on community outreach and intensive case management in order to successfully treat those living with HCV who require a high level of support. In addition, we work with the HCV treatment providers to develop education and awareness tools specific to this population,” says Tamara Barnett, Primary Care Nurse Clinician at Cool Aid Community Health Centre.

 

Up to 35% of all HCV infections in Canada are among immigrants and newcomers, especially those from countries where HCV is common.1 Although voluntary HCV screening after arrival in Canada is included in existing national recommendations, immigrants and newcomers are less likely to access the healthcare system than Canadian-born residents, and healthcare providers may be unaware of countries where HCV is common.1

 

“At the Jewish General Hospital, we see thousands of people on a yearly basis with a variety of liver diseases. A significant number of them are immigrants and newcomers. Hepatitis C is one of the common diseases that we find among this population. I must say that we have a great referral system with our local community health centres,” explains Dr. Nir Hilzenrat, Gastroenterologist and Hepatologist. “Today, we have the right treatments to eliminate hepatitis C, but if we are to reach the goal set by the World Health Organization, we need to work on prevention, as well as screening and linking to care people living with this disease. For me, it’s important to work with the Priority populations to educate them in order to remove any barriers and facilitate understanding so that they can be successfully treated and cured.”

 

Sunday, July 28, marks World Hepatitis Day. Ahead of this date, AbbVie held an HCV Awareness and Screening Day for its employees providing an opportunity to learn more about the disease and to get tested on a voluntary basis. On July 18, close to 30% of head office employees participated seeking to get answers to better understand the myths, facts and stigma surrounding this devastating and deadly disease.

 

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 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed July 2019.

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

AbbVie Receives Positive Recommendation from the Institut national d’excellence en santé et en services sociaux (INESSS) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

  • INESSS recommends the reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL).i
  • Adult patients with CLL taking VENCLEXTA in combination with rituximab can stop their therapy

 

 

Montreal, QC, June 25, 2019 –AbbVie (NYSE: ABBV), a global

biopharmaceutical company, today announced that the Institut national d’excellence en santé et en services sociaux (INESSS) recommends that the Minister include Venclexta, in combination with rituximab, on the Lists of Medications for the treatment of chronic lymphocytic leukemia (CLL), if the following conditions are met: exceptional medication and lessening of the economic burden.i VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients are able to stop their therapy after two years of treatment.

INESSS concludes that the evaluation of venetoclax’s efficacy and safety in combination with rituximab is

based on a good-quality study. The outcomes of that study demonstrated that venetoclax delays disease progression compared to intravenous chemotherapy. Although intravenous chemotherapy is not included on the Lists of Medications, INESSS has recognized its efficacy.i The most common adverse reactions with venetoclax in combination with rituximab were related to white blood cells. Furthermore, there is an unmet clinical need in CLL. The reimbursement of venetoclax in combination with rituximab would be beneficial in the care pathway of CLL patients. i

“The INESSS recommendation for VENCLEXTA plus rituximab is positive news for people living with CLL

in Quebec,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are highly effective treatments available provides reassurance to people facing this uncertain journey.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iii The goal of treatment is to delay progression of the disease and improve quality of life.

 

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.

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. 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 Institut national d’excellence en santé et en services sociaux (INESSS). Avis à la Ministre. www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Mai_2019/Venclexta_2019_05.pdf. Accessed June 2019.

ii Lymphoma Canada. Chronic lymphocytic leukemia. Available at www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed June 2019.

iii Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed June 2019.

iv VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed June 2019.

AbbVie’s MAVIRETTM now listed on the Nova Scotia and Manitoba formularies

  • 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), June 10, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed on the Nova Scotia Formulary and on the Manitoba Drug Benefits and Interchangeability Formulary, both effective since May 31, 2019. 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.*

 

“In Nova Scotia, it is possible to reach the World Health Organization’s target of eliminating viral hepatitis as a major public threat by 2030. But in order to be successful, we need to implement strategies that include prevention, screening, timely and rapid testing, effective treatment and patient centred care for everyone living with hepatitis C,” says Dr. Lisa Barrett, MD, PhD, FRCPC, Assistant professor, Division of Infectious Diseases , Department of Medicine , Department of Microbiology & Immunology, Dalhousie University. “Today, with treatments including MAVIRET, we should be able to treat almost all people living with hepatitis C infection regardless of their background. This is very important for each individual person but also for elimination because treatment helps prevent the spread of HCV.”

 

MAVIRET is listed on the                                          for treatment-naive or treatment-experienced adult

patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.3

 

“At the Hepatitis Outreach Society of Nova Scotia (HepNS), we’ve worked over the last decade to

promote healthy living through information and support for people living with hepatitis C. But more

importantly, we’ve been committed to reducing the transmission rates. We are hopeful that with newer medications like MAVIRET being available in Nova Scotia and New Brunswick, our members will be able to seek the appropriate treatment and finally shed the stigma associated with this disease,” explains Alex MacDonnell, Acting Executive Director of HepNS.

 

MAVIRET is listed on the                                                                                                                                for treatment-naive

or treatment-experienced adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.4

 

“Hepatitis C is a serious health concern. When left untreated it leads to complications including liver cancer,” explains Dr. Kelly Kaita, Hepatologist, Director, Viral Hepatitis Investigative Unit at the

University of Manitoba. “Today, we have the knowledge and the expertise to test, diagnose and treat Canadians living with this deadly disease. Moreover, we have the right treatments, such as MAVIRET,

 

that can cure the disease in as little as eight weeks. Now is the time to act, especially as we are working

towards eradicating this virus by 2030.”

 

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 Hepatitis C

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.5 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.6 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

About MAVIRET

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults across all major genotypes (GT1-6).7 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.7

 

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.7 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.7

 

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 Care

Canadians prescribed MAVIRET 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, personalized education and ongoing disease management support throughout the treatment.

 

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 June 2019. 3 Nova Scotia Pharmacare. Nova Scotia Formulary.

https://novascotia.ca/dhw/pharmacare/pharmacists_bulletins/Pharmacists_Bulletin_May_19-04.pdf. Accessed June 2019. 4 Manitoba Pharmacare Program. Manitoba Drug Benefits and Interchangeability Formulary. www.gov.mb.ca/health/mdbif/bulletin104.pdf. Accessed June 2019.

5 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed June 2019.

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

7 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.pdf . Accessed June 2019.

AbbVie Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

  • pERC conditionally recommends reimbursement of 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
  • Adult patients with CLL taking VENCLEXTA in combination with rituximab

 

 

Montreal, QC, June 6, 2019 –AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) conditionally recommends reimbursement of 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, irrespective of their 17p deletion status, only if the following condition is met: cost-effectiveness being improved to an acceptable level.i VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients can able to stop their therapy after two years of treatment.

“The pCODR recommendation for VENCLEXTA plus rituximab is positive news for Canadians living with

CLL,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are highly effective treatments available provides reassurance to people facing this uncertain journey.”

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodii, is one of the most

common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iii The goal of treatment is to delay progression of the disease and improve quality of life.

 

“This is another tremendous milestone in our efforts to bring VENCLEXTA plus rituximab to Canadians living with CLL. This is a much needed treatment option as it is the first chemotherapy-free combination in CLL that allows patients a 24-month treatment duration,” says Stéphane Lassignardie, General Manager of Abbvie Canada.

 

 

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.

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

 

 

ii Lymphoma Canada. Chronic lymphocytic leukemia. Available at www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed June 2019.

iii Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed June 2019.

iv VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed June 2019.

AbbVie’s MAVIRETTM now listed in New Brunswick

  • 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), May 30, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed on the New Brunswick Drug Plans Formulary. 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.*

 

“Hepatitis C is the leading cause of liver failure and liver cancer in New Brunswick,” states Dr. Meaghan O’Brien, Hepatologist, Upper River Valley Hospital, Assistant professor, Division of General Internal Medicine, Department of Medicine, Dalhousie University. “With the introduction and subsequent approval and reimbursement of the new direct-acting antiviral therapies, such as MAVIRET, we have an opportunity to treat all Canadians living with this devastating and deadly disease. However, we need to ensure that the proper models of care are in place in order to reach our objectives both locally and across Canada.”

 

On the New Brunswick Drug Plans Formulary, MAVIRET is listed for treatment-naïve or treatment- experienced adult patients with chronic hepatitis C virus (HCV) including all genotypes 1-6. The listing became effective on May 16, 2019.3

 

“AbbVie believes that together, through innovative partnerships, we can make hepatitis C elimination the next public health success story. Along with healthcare professionals, governments and patient associations, together we can meet the WHO 2030 objective,” says Stéphane Lassignardie, General Manager, AbbVie Canada. “We are committed to further investigating and identifying opportunities to simplify the path to a cure.”

 

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).

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.4 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.5 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare

 

systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

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 Care

Canadians prescribed MAVIRET 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, personalized education and ongoing disease management support throughout the treatment.

 

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 May 2019. 3 New Brunswick Prescription Drug Program. www2.gnb.ca/content/dam/gnb/Departments/h- s/pdf/en/NBDrugPlan/FormularyUpdates/NBDrugPlansBulletin999.pdf. Accessed May 2019.

4 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed May 2019.

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

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA®, a treatment for chronic lymphocytic leukemia (CLL)

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Ontario is the first province to reimburse
  • VENCLEXTA is the first and only BCL-2 inhibitor to be approved in
  • A need exists for CLL patients who have failed novel oral i

 

Montreal, QC, May 23, 2019 – AbbVie (NYSE: ABBV), a global, research and development-driven biopharmaceutical company, announced today that Ontario is the first province to reimburse VENCLEXTA® (venetoclax) monotherapy under its Drugs and Devices Division’s (DDD) Exceptional Access Program effective May 13, 2019.ii VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have no other treatment options. VENCLEXTA is an oral, once-daily medicine.

 

This listing follows the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA) earlier this year.

 

“People living with chronic lymphocytic leukemia in Ontario finally have access to VENCLEXTA, which is great news considering the nature of this disease. When faced with CLL, which can be recurrent, it is important to offer physicians and their patients highly effective options to tackle this illness,” explains Elizabeth Lye, Director of Research & Programs at Lymphoma Canada. “At Lymphoma Canada, we hope that soon all Canadians will have access to this treatment.”

 

VENCLEXTA monotherapy will be available through the Exceptional Access Program for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have failed treatment with at least one prior therapy (including B-cell receptor inhibitors) or who have experienced intolerance to ibrutinib.

 

“When I meet a patient for the first time, I always explain that CLL is a type of blood cancer that is chronic and that some may relapse after being in remission. In fact, most of the patients I see in my clinic have often already gone through another line of treatment. Therefore, I want to ensure I have the appropriate treatments available for my patients in a timely manner,” says Dr. Peter Anglin, MD, FRCPC,

MBA, Hematologist and Physician Lead, Stronach Regional Cancer Centre. “I am thrilled that Ontario is

the first province to reimburse venetoclax; it’s a positive step for people living with CLL who need access to this much needed treatment.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodiii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iv

 

“It’s been a long time coming for wonderful news like this. I can remember reading about clinical trials for this treatment several years ago and thinking how promising it sounded for people like me who have already been treated with more than one line of therapy and relapsed,” states Mark Silverstein of

Aurora, Ontario. “Now it’s finally here! Another treatment option in the CLL world has been approved and reimbursed in the province of Ontario, and hopefully soon coming to every Canadian province. And thank you AbbVie for your commitment to bringing VENCLEXTA to those who need it.”

 

VENCLEXTA received a Notice of Compliance with Conditions (NOC/c) from Health Canada on September 30, 2016. The therapy was approved as monotherapy for previously treated CLL patients, who have either a genetic mutation known as 17p deletion, or who do not have the mutation but have no other available treatment options, and who have received at least one other therapy. The 17p deletion is a genetic mutation that is found in 3 to 10 percent of people with previously untreated CLL and up to 50 percent of relapsed or refractory cases.v Under Health Canada’s NOC/c policy, AbbVie will provide Health Canada with data from additional studies to assess the clinical benefit of VENCLEXTA in these patient populations.vi

 

“This agreement with the pCPA and subsequently the listing in Ontario are positive steps towards patients living with CLL accessing a medication that serves an unmet medical need,” stated Stéphane Lassignardie, General Manager of AbbVie Canada. “AbbVie is committed to changing the way blood cancers are treated with innovative new treatment options.”

 

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

 

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

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.

 

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

 

iJain P. et al. Long-Term Outcomes for Patients With Chronic Lymphocytic Leukemia Who Discontinue Ibrutinib. Cancer. 2017 Jun 15;123(12):2268-2273.

ii Ontario Ministry of Health and Long-Term Care. http://health.gov.on.ca/en/pro/programs/drugs/eap_mn.aspx. Accessed May 2019.

iii Lymphoma Canada. Chronic lymphocytic leukemia. Available at http://www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed May 2019.

iv Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. http://www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 2019.

v Schnaiter A. et al. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin N Am. 2013;27:289–301.

vi VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed May 2019.

AbbVie Launches ORILISSATM (elagolix) 200 mg BID Dose 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

 

Montreal, QC, May 21, 2019 – AbbVie (NYSE: ABBV), a global, research and development-driven biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that ORILISSA™ (elagolix) 200 mg twice daily is now available. ORILISSA is the first and only oral gonadotropin-releasing hormone receptor (GnRHr) antagonist, for the treatment of moderate to severe pain associated with endometriosis.3

 

“Endometriosis is a misunderstood and often mismanaged disease. It has been estimated that on average, it takes 9-10 years for a woman to receive a diagnosis of endometriosis. This is often because patients themselves and physicians normalize the pain these patients are experiencing. This can have a huge impact on their quality of life, relationships and work productivity, Even diagnosed women who suffer from it tend to normalize their pain and downplay the effects it has on all aspects of their lives,” says Dr. Jamie Kroft MD, MSc, FRCSC, Assistant Professor, Minimally Invasive Gynaecologic Surgery, Core Obstetrics & Gynaecology, Sunnybrook Health Sciences Centre. “The women I see in my practice always have a lot of questions, especially around appropriate medical management. I take the time to explain their options so they can make an informed decision. Therefore, the more options that are available, for example ones that are hormone-free and can be customized to my patients’ needs, the better I can treat them. Women should not suffer in silence, especially not when there are new treatment advances.”

 

ORILISSA (elagolix) is a novel, orally administered, highly potent, short-acting, selective, non-peptide small molecule GnRHr 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

 

“At the Endometriosis Network Canada, we encourage our members to become informed and empowered. Having an accurate diagnosis and getting treatment from an endometriosis expert are important steps in attaining relief from their symptoms. Although endometriosis is currently incurable, there are effective treatments available and in partnership with their healthcare professionals, patients can work on a treatment plan that works for them. Ultimately, we know what people living with this debilitating disease want is to live fulfilling and pain-free lives, where they are able to pursue any

endeavour, both professionally and personally,” explains Philippa Bridge-Cook, Ph.D., Executive Director of The Endometriosis Network Canada.

 

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

 

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 three most common types of endometriosis pain: dysmenorrhea, non-menstrual pelvic pain and dyspareunia. 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 clinically meaningful 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

 

“We are proud to launch the ORILISSA 200 mg strength. With this dose, we are able to offer physicians the unique ability to individualize the care of their patients. Women with endometriosis now have a hormone-free choice that is customizable based on their unique needs,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “AbbVie is committed to women living with endometriosis as we strive to fill the unmet medical need by providing a safe and efficacious treatment.”

 

About AbbVie Care

Canadian women prescribed ORILISSA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature support program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout their treatment. 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/. Accessed May 2019.

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 4, 2018. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/ORILISSA_PM_EN.PDF. Accessed May 2019.

Health Canada Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

  • SKYRIZI™(risankizumab) is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit to treat moderate to severe plaque psoriasis1 . IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune
  • Approval of SKYRIZI™ (risankizumab) is based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3 month dosing in more than 2000 adult patients 2-5

 

Montreal, Quebec, April 18, 2019 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced today that Health Canada has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program.

 

In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).2-5

 

“When treating patients with a chronic disease like psoriasis, it is important to have several options available. With SKYRIZI™, we can simplify their treatment by offering a greater chance of clear skin with a safe and easy three-month dosing regimen. As a dermatologist, this allows me to spend the time I have with my patients on other issues pertaining to their overall health and well-being,” said Dr. Melinda Gooderham, Dermatologist from the SKiN Centre for Dermatology in Peterborough, Ontario.

 

Kathryn Clay, President, Canadian Association of Psoriasis Patients added “Psoriasis is a chronic condition affecting more than one million Canadians and many patients still do not reach their treatment goals or lose response to medication over time so we need options for them.

Despite tremendous progress, there is still much to be done as highlighted in our report Treat Psoriasis Seriously.”

 

 

 

 

 

 

 

 

Stéphane Lassignardie, General Manager, AbbVie Canada added: “We are committed to continuing to find new and better medications that will improve the lives of those living with psoriasis. There are still areas of unmet medical need and we are thrilled that people will be able to access SKYRIZI™.”

 

SKYRIZI™ received Health Canada approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.2-5 SKYRIZI™ is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

 

Highlights from the pivotal Phase 3 program

  • In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI™ I met the co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 (p<0.001).1,4 After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI™ patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI™ in both studies achieved PASI 2,4,5

 

  • Among patients with sPGA of 0/1 at Week 28 in the IMMhance study, 87.4% (97/111) maintained response with continued treatment with SKYRIZI™ compared to 61.3% (138/225) with withdrawal (placebo) at Week 525.

 

  • SKYRIZI™ demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at Week 16 (p<0.001).2,4 Following re-randomization at Week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI™ achieved PASI 90, compared to 21 percent who continued on adalimumab at Week 44 (p<0.001).2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 were met (p<0.001).2,4, 5

 

 

  • SKYRIZI™ was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI™ self- reported a Dermatology Life Quality Index (DLQI) score of 0/1 (no impact on health- related quality of life) at Week 16 (66 percent in ultIMMa-1 and 67 percent in ultIMMa-2) compared with ustekinumab (43 percent in ultIMMa-1 and 47 percent in ultIMMa-2)2,5

 

 

 

 

 

 

 

 

  • The most frequently reported adverse drug reactions through the 16-week placebo- controlled period in the SKYRIZI™ group were upper respiratory tract infections (13%) compared with 10% in the placebo group. Common adverse reactions occurring in ≥ 1% of patients treated with SKYRIZI™ included tinea infections, headache, pruritus, fatigue and injection site 4, 5

 

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 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:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

 

 

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References:

  1. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J 2017 Apr 20; 376:1551-1560.
  2. Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
  3. Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate- to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology 2018.

 

 

 

 

 

 

 

 

  1. Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219):
  2. SKYRIZI™ (risankizumab) [Canadian Product Monograph]. AbbVie Corporation,