MAVIRET® (glecaprevir/pibrentasvir) Approved by Health Canada for Pediatric Patients with Chronic Hepatitis C

MAVIRET® (glecaprevir/pibrentasvir) Approved by Health Canada for Pediatric Patients with Chronic Hepatitis C

  • MAVIRET can now be used as an 8-week, once-daily paediatric granule formulation option in treatment-naïve, without cirrhosis or with compensated cirrhosis, chronic Hepatitis C (HCV) paediatric patients aged 3 to <12 years with genotype (GT)1-6, weighing at least 12kg to less than 45kg
  • Health Canada’s decision makes MAVIRET the first pan-genotypic treatment option for treatment-naïve, compensated cirrhotic, chronic HCV patients as young as 3 years of age and weighing 12kg or more
  • This approval is supported by 98.4 per cent cure* rate across this group of patients who received the approved paediatric granule formulation

Montreal, QC, June 22, 2022 – AbbVie (NYSE: ABBV) announced today that Health Canada has approved a change in the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to include its use for the treatment in paediatric patients 3 to 12 years old, weighing at least 12kg to less than 45kg.1 MAVIRET is now approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older.1** “There is an estimated 250,000 people living in Canada with chronic hepatitis C including young children who I have witnessed first-hand at SickKids in need of treatment options,” said Dr. Simon Ling, MBChB, MRCP(UK), Division of Gastroenterology, Hepatology and Nutrition, SickKids Toronto. “The approval of MAVIRET® as a paediatric indication is a necessary step that will add a beneficial therapeutic option to treat HCV infection in children.” The label extension is supported by data from the phase 2/3, non-randomized, open-label, multicenter DORA Part 2 study evaluating the safety and efficacy of weight-based dosing of glecaprevir/pibrentasvir (G/P) granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years with chronic HCV infection.1 Patients received a paediatric formulation of glecaprevir (GLE)/pibrentasvir (PIB), comprised of film-coated granules of GLE and PIB, in a sachet mixed together in a small amount of soft food for once-daily oral administration. The mixture of food and granules should be swallowed immediately; the granules should not be crushed or chewed.1 “With Canada’s commitment to eliminating viral hepatitis as a public health threat by 2030, the approval of MAVIRET ® for paediatric patients is a positive advancement in reaching our goals,” said Jennifer van Gennip, Executive Director, Action Hepatitis Canada. “Now with access to treatment of viral hepatitis amongst children, one more barrier to elimination is removed.” In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62)1 . No subject taking the final recommended dose experienced virologic failure1 . The adverse reactions observed in patients 3 less than 12 years of age were consistent with those observed in clinical trials of MAVIRET in adults with the exception of vomiting (occurring at approximately 8%), rash, and abdominal pain upper (each occurring at approximately 4%) which were observed more frequently than in adults.1 “MAVIRET has had a significant impact on the lives of people affected by chronic HCV, and we are pleased that pediatric patients are now also able to benefit from this treatment option,” said Tracey Ramsay, Vice-president and General Manager, AbbVie Canada. “We are committed to helping achieve the World Health Organization’s 2030 goal of HCV elimination and we believe Health Canada’s expanded approval for MAVIRET will help Canadians to get one step closer.” About the DORA part 2 Study2 The efficacy, safety and pharmacokinetics of G/P in children 3 years to less than 18 years old was demonstrated in an open-label study which was comprised of two parts, DORA Part 13 and Part 22 . DORA Part 2 evaluated the safety and efficacy of weight-based dosing of G/P granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years. 18 subjects received the initial lower dose, and 62 subjects received the final recommended dose. The median age was 7 years (range: 3 to 11); 73% had HCV genotype 1, 3% had genotype 2, 23% had HCV genotype 3, 3% had HCV genotype 4; 55% were female; 4% were Black; 97.5% were HCV TN; 2.5% were treatment-experienced to interferon; 1% had HIV-coinfection; none had cirrhosis; the mean weight was 25 kg (range: 13 to 44). In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62). No subject taking the final recommended dose experienced virologic failure. One 9-year-old child with HCV GT3b infection, who had received the initial lower dose, experienced virologic failure. The child had K30R and V31M at baseline and treatment-emergent Y93H at relapse in NS5A; baseline or treatmentemergent substitutions were not detected in NS3. The pattern of adverse reactions observed was comparable with that observed in clinical studies of G/P film-coated tablets in adolescents and adults. About MAVIRET™ (glecaprevir/pibrentasvir)1,2 MAVIRET® is approved by Health Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults and children 3 years and older across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets. The new paediatric formulation consists of MAVIRET coated granules in sachet. Each sachet contains 50mg of glecaprevir and 20mg of pibrentasvir. The recommended dosage in number of sachets is based on body weight for children1 . MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment**. 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 kidney1 disease (CKD). MAVIRET is a pangenotypic treatment approved for use in patients across all stages of CKD. 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. MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B).1 For important safety information, please consult the MAVIRET Product Monograph at www.abbvie.ca. About Hepatitis C An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 40% 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 AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn. -30- Media: Muriel Haraoui AbbVie Canada 514-717-3764 muriel.haraoui@abbvie.com *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. **The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis. 1AbbVie Canada. Maviret Product Monograph. Retrieved https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/MAVIRET_PM_EN.pdf. April 2022. 2 Jonas MM et al. Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in children with chronic hepatitis C virus: part 2 of the DORA study. J Hepatol (2021) 3 Jonas, MM et al. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. J Hepatol (2020) 4Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf Accessed April 2022. 5Canadian Liver Foundation. How you advocate. https://www.liver.ca/how-you-help/advocate/ Accessed April 2022.

Health Canada Approves VRAYLAR® (cariprazine) for the Treatment of Bipolar l Disorder and Schizophrenia in Adults

Health Canada Approves VRAYLAR® (cariprazine) for the Treatment of Bipolar l Disorder and Schizophrenia in Adults

VRAYLAR® is a new atypical antipsychotic medication with partial agonist activity at central dopamine D3 receptors in addition to targeted activity at D2 and serotonin 5-HT1A and 5-HT2A receptors. 1

MONTREAL, April 27, 2022 /CNW Telbec/ – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that Health Canada has approved VRAYLAR® (cariprazine) as monotherapy for the acute management of manic, mixed, and depressive episodes associated with bipolar l disorder in adults, as well as the treatment of schizophrenia in adults.1

AbbVie Canada. (CNW Group/AbbVie Canada)
AbbVie Canada. (CNW Group/AbbVie Canada)

Bipolar I disorder is a mental illness characterized by extreme mood swings that can impact an individuals’ ability to think, behave and function.2 It can consist of three states which includes manic, depressive, and mixed episodes.While the causes of bipolar I disorder are unknown, biological factors can play a role and can be difficult to diagnose due to the wide range of symptoms.3

Schizophrenia is a severe mental illness that can also impact a person’s ability to function, and often presents symptoms that can change over time. Symptoms can include hallucinations, disorganized speech, social withdrawal, and catatonic behaviour.3

“I have seen firsthand what impact bipolar l disorder and schizophrenia can have on a person’s life. These are complex illnesses that can be difficult to treat and manage. It is important that we have additional treatment options available for persons affected,” says Dr. Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology, University of Toronto“As a healthcare professional, I am pleased to hear that this treatment is now available for Canadians who live with bipolar l disorder or schizophrenia.”

It’s estimated 2.2% of Canadians will experience bipolar l disorder in their lifetime and can impact both men and women equally,4 while an estimated 300,000 Canadians are impacted by schizophrenia.3 Stigma remains prevalent in both disorders, with patients often experiencing discrimination and difficulty in accessing resources and treatment.5

“We know that living with bipolar l disorder can present various challenges impacting the daily lives of patients and their families,” Dave Gallson, National Executive Director, Mood Disorders Society of Canada. “The Mood Disorders Society of Canada thanks Health Canada for the approval of VRAYLAR®, which will support those in the community in managing this mental illness. It is encouraging to see new treatment options for people with bipolar I disorder.”

“We are pleased to see the progress in new treatments to support Canadians living with schizophrenia,” says Chris Summerville, CEO of the Schizophrenia Society of Canada. “Patients are looking for convenient and safe treatments to support their health and recovery. VRAYLAR® will offer new hope for many Canadians and help minimize the burdens associated with schizophrenia to support patients and their caregivers.”

“Mental illness affects many Canadians either through personal experience, or that of a family member, friend, or colleague,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada. “The approval of VRAYLAR® is an important milestone that will support patients suffering from bipolar I disorder and schizophrenia. At AbbVie, we are committed to providing new treatment options to enhance patient care and support the unmet needs of mental illness community.”

About VRAYLAR® (cariprazine) 1
VRAYLAR® is an oral, once daily atypical antipsychotic approved as monotherapy for the acute management of manic, mixed, and depressive episodes associated with bipolar l disorder in adults, as well as the treatment of schizophrenia in adults.

The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at central dopamine D3, D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding and functional activity profiles similar to the parent drug.

VRAYLAR® is contraindicated in patients who are hypersensitive to cariprazine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. VRAYLAR® is also contraindicated with concomitant use with strong and moderate CYP3A4 inhibitors / inducers. Due to the slow elimination of cariprazine and its metabolites, treatment with strong and moderate CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR discontinuation.

VRAYLAR is being developed jointly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in the U.S., Canada, Japan, Taiwan and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru and Venezuela).

Please consult the VRAYLAR® Product Monograph at www.allergan.ca.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

VRAYLAR Product Monograph. Allergan Inc. April 22nd 2022.
2 CAMH. Bipolar Disorder. Retrieved from https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/bipolar-disorder. Accessed March 2022.
Schizophrenia Society of Canada. Learn more about Schizophrenia. Retrieved from https://schizophrenia.ca/learn-more-about-schizophrenia/ . Accessed March 2022.
Canadian Psychological Association. “Psychology Works” Fact Sheet: Bipolar Disorder. Retrieved from https://cpa.ca/psychology-works-fact-sheet-bipolar-disorder/. Accessed March 2022.
CAMH. Addressing Stigma. Retrieved from https://www.camh.ca/en/driving-change/addressing-stigma. Accessed March 2022.

SOURCE AbbVie Canada

Cision
Cision

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AbbVie Expands Immunology Portfolio in Canada as Health Canada approves SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis

AbbVie Expands Immunology Portfolio in Canada as Health Canada approves SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis

  • Approval supported by data from two Phase 3 studies evaluating SKYRIZI in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-21,2
  • Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis3,4,5

MONTREAL, March 17, 2022 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced Health Canada has approved SKYRIZI® (risankizumab), for the treatment of adult patients with active psoriatic arthritis. In PsA, SKYRIZI can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

“SKYRIZI receiving Notice of Compliance for the treatment of active psoriatic arthritis gives additional hope to patients. Results from the Phase 3 clinical trial program indicate improvement in the signs and symptoms associated with this disease,” said Dr. Kim Alexander Papp, MD, PhD, FRCPC, FAAD, Probity Medical Research.

“At AbbVie, we strive to transform the standard of care for immunocompromised people, and we are excited with Health Canada’s approval of SKYRIZI for the treatment of adults with active psoriatic arthritis,” said Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

This is the second indication for SKYRIZI in Canada. In April 2019, Health Canada approved SKYRIZI for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.6

About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and the presence of psoriatic lesions.4,5

About KEEPsAKE-1 and KEEPsAKE-21,2
KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARD.

About SKYRIZI® (risankizumab)6
Risankizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits IL-23, a cytokine involved in inflammatory and immune responses.

For important safety information, please consult the SKYRIZI Product Monograph at www.abbvie.ca.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

1 Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial.
2. Östör, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.
3. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on October 25, 2021.
4. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003
5. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on October 25, 2021
6. AbbVie Product Monograph. March 2022. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf

SOURCE AbbVie Canada

Focusing on the silent thief of sight during World Glaucoma Week

Focusing on the silent thief of sight during World Glaucoma Week

New survey reveals 45% of Canadians living with glaucoma had no prior knowledge of their disease before diagnosis

MONTREAL, March 9, 2022 /CNW/ – It’s estimated 728,000 Canadians are living with glaucoma.1 The estimate for people living with vision loss in Canada is likely greater.2 Known as the ‘silent thief of sight’, glaucoma is an eye disease where increased intraocular pressure can damage the optic nerve and lead to permanent vision loss.3 Vison loss symptoms can be difficult to recognize. If glaucoma is diagnosed at an early stage, treatment can usually control or prevent further vision loss.4 If left untreated, permanent vision loss of some form is likely to occur.5

Allergan, an AbbVie Company (CNW Group/Allergan, an AbbVie Company)
Allergan, an AbbVie Company (CNW Group/Allergan, an AbbVie Company)

This week marks World Glaucoma Week – a global initiative that takes place between March 6-12, to increase disease awareness and encourage those at risk to seek regular eye exams.

A national survey, conducted by Leger Research, engaged 150 Canadians living with glaucoma, to understand challenges, needs and insights surrounding their glaucoma experience.

Survey findings revealed6 :

  • 69% of respondents don’t know what type of glaucoma they have
  • 22% of respondents experienced some vision loss before being diagnosed with glaucoma
  • The average age of glaucoma diagnosis is 51. Regionally, Quebecers were significantly more likely to be diagnosed between age 26-41 and between 42-57 and less likely to have had a diagnosis at age 65+.
  • 59% of glaucoma patients say at least one of their family members has also been examined to check if they have glaucoma

The survey also revealed that 65% of respondents rely on their doctor’s office for new resources and information to support their understanding of glaucoma, and 39% of respondents search online. While there is no cure for glaucoma, access to resources and information can help enhance glaucoma management and improve patient outcomes.

Canadians are encouraged to learn about the effects of glaucoma, get their eyes checked for glaucoma to support early diagnosis and access resources such as Fighting Blindness Canada website (FightingBlindness.ca).

For more information on World Glaucoma Week visit https://www.worldglaucomaweek.org/

About Survey
Commissioned by Allergan, an AbbVie Company, the survey was conducted using Leger’s online panel between February 24-26, 2022, with 150 Canadians who have been diagnosed with glaucoma. The estimated margin of error is ±8.0 %, 19 times out of 20.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

1 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/ Accessed March 2022.
2 The cost of vision loss and blindness in Canada. Canadian Council of the Blind. May 2021. Retrieved from https://www.fightingblindness.ca/wp-content/uploads/2021/12/Deloitte-Cost-of-vision-loss-and-blindness-in-Canada-report-May-2021.pdf. Accessed March 2022.
3 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/ Accessed March 2022.
4 Canadian Association of Optometrists. Glaucoma fact sheet. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed March 2022.
5 Canadian Association of Optometrists. Glaucoma fact sheet. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed March 2022.
6 Leger Research. Glaucoma Survey commissioned by Allergan, an AbbVie Company. Online survey of 150 Canadians who have been diagnosed with glaucoma, between February 24-26, 2022, using Leger’s online panel

SOURCE Allergan, an AbbVie Company

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Cision

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AbbVie Announces Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) in Alberta, Saskatchewan, British Columbia, and Manitoba

AbbVie Announces Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) in Alberta, Saskatchewan, British Columbia, and Manitoba

MONTREAL, Feb. 24, 2022 /CNW/ – AbbVie (NYSE: ABBV) announced today that Alberta, Saskatchewan, British Columbia, and Manitoba now reimburse VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.1 For full funding criteria, consult the list of medications in effect in each province.2,3,4,5 The combination treatment is also listed on the Drug Benefit List in the Non-Insured Health Benefits (NIHB) Program6 and has been on Québec’s Listes des médicaments – Établissements since last November.7

“As a clinician, it’s always best to have several treatment options available for my patients to treat their CLL. It is great news that venetoclax plus obinutuzumab 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. We have been awaiting this time-limited targeted therapy option for CLL patients.”

VENCLEXTA plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated CLL.

“Lymphoma Canada is pleased that this combination therapy is now available in British Columbia, Alberta, Saskatchewan and Manitoba for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients additional treatment options in the frontline setting,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

VENCLEXTA in combination with obinutuzumab, is the third indication for VENCLEXTA for the treatment of CLL. VENCLEXTA is a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of patients with CLL with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options.1

“We are very proud of this tremendous milestone. VENCLEXTA plus obinutuzumab is now reimbursed in Alberta, Saskatchewan, British Columbia, and Manitoba for people living with CLL. This combination is a much-needed treatment option and reinforces our commitment in Oncology. At AbbVie, we stand by our mission to transform the standard of care for people living with cancer,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

CLL, which is typically a slow-progressing cancer of the bone marrow and blood, 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.8

VENCLEXTA 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 AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

________________________________
AbbVie Corporation Venclexta(R) (venetoclax) Product Monograph. Date of Preparation: September 27, 2016. Date of Revision: January 21, 2021.https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf Accessed February 23, 2022.
BC Cancer. http://www.bccancer.bc.ca/systemic-therapy-site/Documents/2022%20ST%20Updates/ST%20Update_Feb%202022.pdf. Accessed February 23, 2022.
Saskatchewan Cancer Agency. http://www.saskcancer.ca/images/pdfs/health_professionals/drug_formulary/drug_formulary/SCA_Drug_Formulary_-_2022-02-01.pdf. February 23, 2022.
Cancer Care Alberta. https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf. Accessed February 23, 2022.
Manitoba Health. Manitoba Drug Benefits and Manitoba Drug Interchangeability Formulary Amendments. https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin116.pdf. Accessed February 23, 2022.
Non-Insured Health Benefits (NIHB) Drug Benefit List. https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407. Accessed February 23, 2022.
Régie de l’assurance maladie du Québec’s Listes des médicaments – Établissements. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments-fournis-etablissement. Accessed February 23, 2022.
Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics.www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed February 23, 2022.

SOURCE AbbVie Canada

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AbbVie and the University of Toronto Establish Endowed Chair in Ethnodermatology

AbbVie and the University of Toronto Establish Endowed Chair in Ethnodermatology

CDN $3-million donation to support diversity in dermatology research, training and care

TORONTO and MONTREAL, Feb. 15, 2022 /CNW/ – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, has made a CDN $3-million donation to establish a pioneering AbbVie Chair in Ethnodermatology at the University of Toronto’s Temerty Faculty of Medicine. One of the first positions of its kind in the world, the Chair will drive collaborative academic research, provide advanced training to the next generation of dermatological practitioners, and lead outreach programs to better inform equitable, diverse and inclusive dermatological care in Canada and around the world.

In a field that focuses on skin, dermatology has a particular responsibility to identify and address racial inequities that influence health outcomes,” says Dr. Patricia Houston, Temerty Medicine’s Acting Dean and Vice-Dean, Medical Education. We now recognize there are major gaps in what we know about and how we teach the approach to assessment and treatment of different skin types. The creation of the AbbVie Chair in Ethnodermatology represents a milestone philanthropic investment in our Faculty’s ongoing efforts to advance health equity, and positions U of T, AbbVie and Canada as global leaders in the emerging field of inclusive dermatology.”

Endowed chairs are maintained in perpetuity and are among the most prestigious appointments in academia. They are a powerful recruitment tool for the most talented clinicians and researchers — allowing for advancement in scholarship and research, while also showcasing a long-term commitment to a specific discipline.

Filling Gaps and Addressing Inequities
The chair’s establishment comes in response to growing calls from clinicians, researchers and patients to address longstanding gaps and inequities in dermatological research, education and patient care. In particular, there is increased recognition of the need for new investigations into the distinct impacts of skin conditions on patients of colour, for better and more in-depth data on the disparities in dermatological care provided to different populations, as well as for greater representation of skin of colour in medical education programs and curricula.

“Richly-pigmented skin is not the same in many ways — the biochemistry, biology and diseases that affect it are different,” says Dr. Marissa Joseph, assistant professor with U of T’s Temerty Faculty of Medicine and medical director of the RKS Dermatology Centre at Women’s College Hospital. “By not studying and learning the differences in presentation of disease in skin of colour, there’s an increased likelihood of misdiagnosis, treatment delays, and/or the application of inappropriate treatment approaches – all of which can have catastrophic impacts on patients. As a clinician and educator, I welcome the creation of the AbbVie Chair in Ethnodermatology and believe it can be a powerful catalyst for change.”

The need for AbbVie’s gift has also never been more relevant – nor more pressing – than it is today. According to Statistics Canada demographic projections, the proportion of Canadians who belong to a visible minority group will increase greatly by 2031. Visible minority groups could soon comprise 63% of the population of Toronto, 59% of Vancouver and 31% of Montreal1.

The inaugural chairholder will have a broad educational and research mandate. This will include leading the development of curricula to ensure future physicians and dermatologists are adequately trained to diagnose and treat skin conditions in persons of colour and to apply principles of inclusive dermatology, as well as undertaking much-needed clinical investigations into skin disorders and diseases’ distinct impact on people of colour.

Tracey Ramsay, Vice-President and General Manager of AbbVie Canada adds, “We believe it is important to ensure all Canadians have equal, fair and inclusive disease care. Equality, diversity and inclusion are among our core corporate principles and the creation of this chair is a step forward in enhancing dermatology diversity and cultural inclusion. Together with U of T, we have an opportunity to be part of a solution that will evolve the way skin care is researched, taught and practiced in Canada and hopefully across the globe.”

Dr. Christina Pelizon, Country Medical Director, AbbVie Canada adds; “We’re focused on delivering treatments in areas of high unmet medical need and as a leader in dermatology research and treatment, AbbVie is committed to the pursuit of innovation. Ultimately, this Chair will provide us a better understanding on how we can continue to make a remarkable impact on the lives of people living with serious skin diseases.”

About the Temerty Faculty of Medicine
Founded in 1843, the University of Toronto’s Temerty Faculty of Medicine consistently ranks among the top medical faculties in the world. More than a quarter of all Canadian physicians train at U of T. Together with the world-renowned hospital partners that make up the Toronto Academic Health Science Network, Temerty Medicine delivers innovative and impactful biomedical research, education and patient care that advance health and health care in Canada and beyond. For more information about Temerty Medicine, please visit temertymedicine.utoronto.ca or follow us on Twitter @uoftmedicine.

About AbbVie
AbbVie is a highly focused research-driven biopharmaceutical company that discovers and delivers innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. AbbVie strives to make a remarkable impact on people’s lives across several therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.

1 “Ethnic diversity and immigration”, Canada Yearbook 2011. Statistics Canada. https://www150.statcan.gc.ca/n1/en/pub/11-402-x/2011000/pdf/ethnic-ethnique-eng.pdf?st=RK5ALCv9

SOURCE AbbVie Canada

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AbbVie Announces First Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia in Quebec

AbbVie Announces First Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia in Quebec

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Quebec is the first province to reimburse the combination treatment.
  • VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).

MONTREALNov. 18, 2021 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that an agreement has been reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.1

Effective November 10, on Québec’s Listes des médicaments, VENCLEXTA is listed in combination with obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia. For full criteria, consult the list of medications in effect.2

“Being able to prescribe a therapy, such as venetoclax in combination with obinutuzumab, that has a finite treatment duration and manageable side effects is a welcomed option for my patients. After completing the prescribed treatment regimen, I can tell them that they can stop their medication because this effective combination helps to delay disease progression,” explains Dr. Sarit Assouline, Physician, Division of Hematology, Sir Mortimer B. Davis-Jewish General Hospital, Senior Investigator, Lady Davis Institute for Medical Research, Associate Professor, Department of Oncology, McGill University.

In October 2020, the Institut national d’excellence en santé et en services sociaux (INESSS) recommended that the Minister include VENCLEXTA, in combination with obinutuzumab, on the Listes des médicaments for the treatment of CLL. INESSS concluded that “the results of the intermediate analysis show that the venetoclax/obinutuzumab combination as first-line therapy in patients with CLL prolongs progression-free survival in a statistically and clinically meaningful way compared to the chlorambucil/obinutuzumab combination.”3

“Lymphoma Canada is pleased that this combination is available on the Listes des médicaments in Québec for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important 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 Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

VENCLEXTA, in combination with obinutuzumab, is the third indication for VENCLEXTA for the treatment of CLL, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of patients with CLL with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options.1

“We are very proud of this tremendous milestone bringing VENCLEXTA plus obinutuzumab to people living with CLL in Quebec. This combination is a much-needed treatment option and reinforces our commitment to people living with blood cancer,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

CLL, which is typically a slow-progressing cancer of the bone marrow and blood[4], 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.5

VENCLEXTA 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 AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio consists of marketed medicines and a robust pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

_____________________________________

1

Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed November 9, 2021

2

Régie de l’assurance maladie du Québec’s Listes des médicaments. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments-fournis-etablissement. Accessed November 9, 2021

3

Institut national d’excellence en santé et en services sociaux. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Novembre_2020/Venclexta_2020_10.pdf. Accessed November 9, 2021

4

Lymphoma Canada. Chronic lymphocytic leukemia.www.lymphoma.ca/lymphoma/lymphoma-101/types-lymphoma/cll. Accessed November 9, 2021.

5

Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics.www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed November 9, 2021.

SOURCE AbbVie Canada

For further information: Muriel Haraoui, AbbVie Canada, 514-717-3764, muriel.haraoui@abbvie.com

#WorldSightDay – All Eyes Encouraged to Focus on Glaucoma

#WorldSightDay – All Eyes Encouraged to Focus on Glaucoma

New national survey reveals 45% of Canadians 50+ are not aware that glaucoma is one of the leading causes of blindness in Canada

Montreal, QC, October 14, 2021 – Today is World Sight Day, a timely opportunity to define the importance of proactive vision care and increase understanding of glaucoma. Glaucoma is an eye disease where increased eye pressure (intraocular pressure) can damage the optic nerve and lead to
permanent vision loss.1

In a new national survey conducted by Leger Research, 45 per cent of Canadians 50+ are not aware that glaucoma is one of the leading causes of blindness in Canada.2

The survey also revealed that 42 per cent of Canadians 50+ have not seen an optometrist within the last 18 months. Furthermore, 24 per cent of Canadians 50+ have experienced vision strain from increased screen time within the last 18 months. Lastly according to the survey, Albertans, Ontarians, Quebecers,
and Atlantic Canadians are significantly more likely to say they suffered vision strain from extra time on computer monitors, smart phones, e-readers and watching television compared to Canadians over 50 in the Prairies.

Glaucoma – Stop the Thief of Sight

It’s estimated 400,000 Canadians are impacted by glaucoma.3
A ‘thief of sight,’ glaucoma develops slowly over time, making it difficult to notice any symptoms. Canadians living with glaucoma may experience a gradual narrowing of their peripheral vision. There is no cure for glaucoma and if not proactively managed it will cause optic nerve damage leading to irreversible loss of sight.3

However, optometrist and ophthalmologists can detect and manage glaucoma. Canadians are encouraged to learn about the effects of glaucoma, and access resources for additional support such as the glaucoma section of the Fighting Blindness Canada website (FightingBlindness.ca).

Glaucoma in Perspective (GiP)

In partnership with Fighting Blindness Canada, Allergan has developed the Glaucoma in Perspective (GiP) app designed to help patients understand the impact of their glaucoma and disease progression.

Created by Professor David Crabb, the GiP app was developed with research and insights into patients’ perception of sight loss with glaucoma. GiP has been used across the United Kingdom with great success and is being adapted for Canada. The Glaucoma in Perspective (GiP) app is coming soon to the Apple Store and Google Play for free download.

#WorldSightDay

To recognize #WorldSightDay, the International Agency for the Prevention of Blindness (IAPB.org) has gathered a group of leading global vision organizations and launched the #LoveYourEyes campaign, encouraging one million people around the world to get their eyes checked by Oct. 14th.

Statements:

  • “World Sight Day is an important event that is coming at an especially timely moment as the pandemic has now been amongst us for over 20 months. Every week, I see several patients that have been lost to follow-up for over a year due to COVID fears of seeing their eye care team and they have now suffered cataclysmic and irreversible loss of vision in one or both eyes. Most
    common diseases like cataract or macular degeneration have early and noticeable symptoms for patients. Glaucoma usually damages the peripheral vision first, so it can go unnoticed by patients as the disease worsens, and thus is known as the “silent thief of sight”. The pandemic has been a tragic eye opener to the consequences of delayed health care in so many areas of
    medicine, and we must do everything possible to address its glaucoma impact right now.” – Dr. David B. Yan, Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto – Glaucoma Service Director, Kensington Eye Institute.
  • “There is no cure for glaucoma. It’s why research is critical. However, early detection and treatment can help prevent damage to the optic nerve and save vision. Anyone can develop glaucoma but there are several different factors that can increase your risk of developing the disease. Know your risks. See your eye care professional annually to establish your eye health baseline. You are not alone. FightingBlindness.ca has tremendous resources to help and there is support and resources like the Glaucoma in Perspective (GiP) app will help manage the effects of glaucoma.” – Doug Earle, President & CEO, Fighting Blindness Canada.
  • “Patients with glaucoma don’t normally exhibit symptoms of vision loss until they receive a proper eye exam. The purpose of the GiP app is to simplify glaucoma to ensure that doctors are able to explain the disease and show an accurate visual representation of glaucoma to newly diagnosed patients. This is an app that makes it simple for patients to adhere to treatment and share information about their disease to their loved ones.”- Dr. Professor David Crabb, GiP app developer and Professor of Statistics and Vision Research, City University London.
  • “Our purpose in Glaucoma is to create a future where people’s vision lasts a lifetime. We understand the importance of eye care, and that’s why we continue to search for new treatments to help preserve and protect our patients’ vision. We’ve been creating innovative products and services for healthcare providers and patients for over 70 years, and we challenge
    what’s possible each and every day. We’re proud to launch the new Glaucoma in Perspective (GiP) app in partnership with Fighting Blindness Canada and remain committed to supporting Canadians living with and managing eye diseases.” – Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

About the Survey

Commissioned by Allergan, an AbbVie Company, the survey was conducted using Leger’s online panel between September 10 to 12, 2021 with 684 Canadians aged 50 and over. The estimated margin of error is ±3.75%, 19 times out of 20.

About Fighting Blindness Canada

Fighting Blindness Canada (FBC) is Canada’s leading private funder of vision research. FBC offers hope to Canadians by identifying the best, most promising research that is driving treatments and cures for blinding eye diseases, and by raising and stewarding funds to support this essential, sight-saving research. Over our 45-year history, FBC has invested over $40 million to support vision research and education across Canada: that’s over 200 research grants that have led to over 600 new discoveries in areas such as stem cell research, neuroprotective therapies, technological developments,
pharmaceuticals, and gene therapies. FBC is also committed to developing vision research funding partnerships in Canada and internationally. Through these partnerships, FBC has helped to unlock more than $10 million to drive research forward. All of the research and educational initiatives funded support the goals of understanding why vision loss occurs, how it can be slowed or stopped, and how sight can be restored.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology,
women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

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

1 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/wpcontent/uploads/2021/03/FBC_OnePager_Glaucoma.pdf . Accessed October 13, 2021
2 Canadian Association of Optometrists. About Glaucoma. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed
October 13, 2021.
3 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/
Accessed October 13, 2021.

Health Canada Approves the Use of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Health Canada Approves the Use of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Moderate to Severe Atopic Dermatitis

  • Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials evaluating the efficacy and safety or RINVOQ (upadacitinib) in monotherapy or in combination with topical corticosteroids.1
  • RINVOQ demonstrated improvements in skin clearance and itch reduction compared to placebo.
  • Milestone marks the third Health Canada-approved indication for RINVOQ1†

MONTREAL, QC, October 7, 2021 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved RINVOQ® (upadacitinib), an oral, once-daily selective JAK inhibitor for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when
use of those therapies is inadvisable. RINVOQ® can be used with or without topical corticosteroids.”

Atopic dermatitis (AD) is characterized by intense uncontrolled itching, dry skin, which becomes cracked, hardened, oozing and painful. It is estimated that up to 17% of Canadians will suffer from AD at some points in their lives. 2

“Atopic dermatitis is a chronic inflammatory skin disease that impacts both patients and caregivers. As atopic dermatitis is common at all ages, it affects many Canadians. I have seen first-hand the debilitating impact of atopic dermatitis on patients through my research and my practice,” states Dr. Kim Alexander Papp, MD, PhD, FRCPC, Probity Medical Research and K.
Papp Clinical Research, Waterloo ON. “If we hope to improve patients’ overall quality of life, clinicians need more tools. Having access to advanced therapies allows us to better support patients and provide them with treatment outcomes that address their unmet needs.”

The Health Canada authorization is supported by data from a large registrational Phase 3 clinical trial program in atopic dermatitis including more than 2,500 adults and adolescents with moderate to severe disease.1 These multicenter, randomized, double-blind, placebo-controlled registrational clinical trials evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 [MU1] and Measure Up 2 [MU2]) and with topical corticosteroids (AD Up [AU]) compared to placebo.1 3 4 In all three studies, the co-primary endpoints were at least a 75 percent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week
16. 1 3 4

Eczema Society of Canada’s Executive Director Amanda Cresswell-Melville highlights the burden of atopic dermatitis. “The impacts of atopic dermatitis on quality of life for both patients and caregivers are often underestimated and misunderstood,” says Cresswell-Melville.

“Patients may be seeking additional options to address their unmet needs in the management of their condition. New treatment options bring hope to these patients.”

Chronic inflammatory skin diseases go well beyond the surface and affect both physical and mental health. The exact cause of atopic dermatitis is unknown, but a combination of immune, genetic, and environmental factors is believed to be involved.3

“AbbVie is dedicated to the pursuit of innovation in life sciences and advancing the standards of care for patients,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

“We are proud of our strong heritage in dermatology and continue to deepen our understanding of the complex nature of serious inflammatory skin conditions. Through this milestone in atopic dermatitis, we remain committed to developing and delivering leading-edge therapies for patients who need them most.”

About RINVOQ® (upadacitinib)
RINVOQ is a once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.
RINVOQ is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.

RINVOQ can be used with or without topical corticosteroids. For therapeutic and important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

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1 RINVOQ (upadacitinib) Product Monograph. AbbVie Corporation. Available at
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf.
2 Canadian Dermatology Association. Eczema https://dermatology.ca/public-patients/skin/eczema/
3 Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-tosevere atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised
controlled phase 3 trials. Lancet. 2021; 397(10290): 2151-2168. doi:10.1016/S0140-6736(21)00588-2.
4 Reich K, Teixeira HD, Bruin-Weller, et al. Safety and efficacy of upadacitinib in combination with topical
corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a
randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169-2181.
5 Eczema Society of Canada. What is eczema? https://eczema

AbbVie receives a positive reimbursement recommendation from the Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for VENCLEXTA® in combination with azacitidine for AML patients

AbbVie receives a positive reimbursement recommendation from the Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for VENCLEXTA® in combination with azacitidine for AML patients

  • pERC recommends reimbursement of VENCLEXTA® (venetoclax) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
  • The VIALE-A trial demonstrated a statistically significant increase in overall survival with VENCLEXTA® in combination with azacitidine compared to placebo in combination with azacitidine alone.1
  • AML is one of the most difficult-to-treat blood cancers with a very low survival rate. 2,4

Montreal, QC, August 26, 2021 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the CADTH pCODR Expert Review Committee (pERC) recommends that VENCLEXTA® (venetoclax) in combination with azacitidine should be reimbursed for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, only if the conditions listed are
met.3 AML is an aggressive and difficult-to-treat blood cancer with a low survival rate.2,4

In Canada, the five-year net survival rate is approximately 21% for people diagnosed with AML in the general population.4

“AML is one of the most common types of leukemia in adults. This cancer progresses rapidly and has a significantly lower survival rate compared to other cancers,” said Dr. Joseph Brandwein, Hematology Division Director and Professor in the Department of Medicine at the University of Alberta.

“The average age is nearly 70, and most older AML patients are not candidates for intensive chemotherapy and stem cell transplantation. For those patients, treatments to date have not been very effective. This new
regimen has demonstrated improved outcomes.”

Overall, pERC concluded that venetoclax plus azacitidine provides a treatment option for older patients and patients with comorbidities that has an impact on the disease and improves survival.3

“I was diagnosed in November 2019 with AML and my treatment plan included VENCLEXTA. I am hopeful that newly diagnosed AML patients will soon have access to this treatment,” said William Levine of Courtice, Ontario.

In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (95% CI, 11.9, 18.7) vs 9.6 months (95% CI, 7.4, 12.7) in patients who received azacitidine in combination with placebo. In the VENCLEXTA plus azacitidine arm, the most frequent
serious adverse reactions (≥ 5%) were febrile neutropenia (30%), pneumonia (23%), sepsis (16%) and hemorrhage (9%).1

“We have reached another important milestone. With this positive recommendation by the pCODR Expert Review Committee, we are one step closer to providing this treatment to all Canadians who need it. At AbbVie, we stand by our mission to transform the standard of care for people living with cancer,” said Tracey Ramsey, Vice President and General Manager, AbbVie Canada.

VENCLEXTA in combination with azacitidine was approved by Health Canada in December 2020. Health Canada’s approval was granted under Project Orbis, an FDA initiative which provides a framework for concurrent submission and review of oncology products among international partners.

Venetoclax 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 AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring
solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio consists of marketed medicines and a robust pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key  therapeutic areas: immunology, oncology, neuroscience, eye care, virology,
women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on Facebook, Instagram, YouTube and LinkedIn.

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Media:
Muriel Haraoui
AbbVie Canada
514-717-3764
muriel.haraoui@abbvie.com
1 AbbVie Corporation Venclexta(R) (venetoclax) Product Monograph. Date of Preparation: September 27, 2016. Date of
Revision: January 21, 2021. https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed August 26, 2021.
2 Leukemia & Lymphoma Society of Canada. Acute myeloid leukemia (AML). https://www.llscanada.org/leukemia/acutemyeloid-leukemia. Accessed August 26, 2021.
3 CADTH. https://www.cadth.ca/venetoclax. Accessed August 26, 2021.
4 Canadian Cancer Society. Survival statistics for acute myelogenous leukemia. https://www.cancer.ca/en/cancerinformation/cancer-type/leukemia-acute-myelogenous-aml/prognosis-and-survival/survival-statistics/?region=on.
Accessed August 26, 2021.