MONTREAL, Nov. 28, 2025 — Leads & Copy — AbbVie (NYSE: ABBV) announced that SKYRIZI® (risankizumab), an IL-23 inhibitor, has received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases.
The CDA-AMC initially recommended SKYRIZI® for Crohn’s disease (CD) and has now recommended it for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE and COMMAND (for UC). AbbVie also concluded a letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI® for UC.
Canada’s Drug Agency has recommended SKYRIZI® (risankizumab) be reimbursed with conditions by public drug plans for treating 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.
The CDA-AMC’s positive recommendation was based on 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 also announced it has 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.
Dr. Christopher Ma, MD, MPH, FRCPC, Cumming School of Medicine, University of Calgary, said that UC can be an incredibly debilitating disease, and patients need effective, safe treatment options that can help restore quality of life. He added that this is a positive step towards ensuring that Canadians living with UC have access to treatment options that can help them achieve remission and improve their long-term outlook.
Gail Attara, CEO of the Gastrointestinal Society, said that the Common Drug Review recommends that the public formularies cover the costs of an additional therapeutic option for ulcerative colitis. She added that this new treatment is so desperately needed and having a new therapy offers more hope and a chance to improve the quality of life by alleviating some symptoms.
Rami Fayed, Vice President and General Manager, AbbVie Canada, said that 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. He added that AbbVie in Canada is encouraged by the opportunity to work with the CDA-AMC and the pCPA throughout this process to provide access to innovative solutions that have the potential to impact eligible patients’ lives.
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 well-being, and productivity. Approximately 120,000 Canadians are estimated to live with UC, and its prevalence continues to rise across the country.
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 treating 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).
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. The company strives 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.
Hind Mahreche
AbbVie Canada
514-348-8175
hind.mahreche@abbvie.com
Source: AbbVie
