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SKYRIZI® (risankizumab) Receives Positive Reimbursement Recommendation by Canada’s Drug Agency for Ulcerative Colitis and AbbVie Concludes Letter of Intent with the pan-Canadian Pharmaceutical Alliance

News Provided by GlobeNewswire2025-11-28

SKYRIZI^® (risankizumab), an IL-23 inhibitor, received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases, initially for Crohn’s disease (CD) and now for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE, COMMAND (for UC).^1,2
AbbVie concludes letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI^® for UC.³

MONTREAL, Nov. 28, 2025 (GLOBE NEWSWIRE) -- Today, AbbVie (NYSE: ABBV) has announced two positive updates for Canadians living with ulcerative colitis (UC).

Canada’s Drug Agency (CDA-AMC) has recommended SKYRIZI^® (risankizumab) to be reimbursed with conditions by public drug plans for the treatment of adults with moderately to severely active UC who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor if certain conditions are met.²

The CDA-AMC’s positive recommendation was informed by feedback from 25 Canadian clinicians and two patient organizations, including the GI Society and Crohn’s and Colitis Canada, ensuring that the voices of those living with UC were considered.

AbbVie has also successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI^® for UC and a Letter of Intent (LOI) has been signed by both parties.³

SKYRIZI

“UC can be an incredibly debilitating disease and patients need effective, safe treatment options that can help restore quality of life,” said Dr. Christopher Ma, MD, MPH, FRCPC, Cumming School of Medicine, University of Calgary. “This is a positive step towards ensuring that Canadians living with UC have access to treatments options that can help them achieve remission and improve their long-term outlook.”

“We are delighted that the Common Drug Review recommends that the public formularies cover the costs of an additional therapeutic option for ulcerative colitis. This new treatment is so desperately needed,” said Gail Attara, CEO of the Gastrointestinal Society, a patient group known by its badgut.org website. “Individuals living with UC are all different, requiring personalized treatment. Having a new therapy offers more hope and a chance to improve the quality of life by alleviating some symptoms.”

“This is a testament to the mutual commitment of AbbVie and the Health Authorities to improve patient access to innovative medicines for inflammatory bowel disease,” said Rami Fayed, Vice President and General Manager, AbbVie Canada. “AbbVie in Canada is encouraged by the opportunity to work in collaboration with the CDA-AMC and the pCPA throughout this process to provide access to innovative solutions that has the potential to impact eligible patients’ lives.”

About Ulcerative Colitis

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease affecting the large intestine, causing persistent inflammation and ulceration of the colon’s lining. Common symptoms include frequent diarrhea, abdominal pain, and rectal bleeding, which can lead to significant impacts on patients’ daily lives, emotional wellbeing, and productivity. Approximately 120,000 Canadians are estimated to live with UC, and its prevalence continues to rise across the country.⁴

About SKYRIZI^® (risankizumab)¹

SKYRIZI^® (risankizumab) is a humanized monoclonal antibody that selectively inhibits interleukin-23 (IL-23), a key cytokine involved in inflammatory processes. SKYRIZI^® is indicated for the treatment of adults with moderately to severely active Crohn 's disease who have had an inadequate response, intolerance, demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. SKYRIZI^® is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, biologic treatment, or a Janus kinase (JAK) inhibitor.

SKYRIZI^® is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, the treatment of adult patients with active psoriatic arthritis and it can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

About AbbVie

AbbVie 's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.ca.

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