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Subject: PDT

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


MONTREAL, April 18, 2019 /CNW/ - AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced today that Health Canada has approved SKYRIZItm (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, SKYRIZItm 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 SKYRIZItm, 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 SKYRIZItm."

SKYRIZItm  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 SKYRIZItm  is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Highlights from the pivotal Phase 3 program

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.

References:

  1. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 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 Congress. 2018.
  4. 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): 30.
  5. SKYRIZItm (risankizumab) [Canadian Product Monograph].  AbbVie Corporation, 2019.

SOURCE AbbVie


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