SKYRIZI (risankizumab)
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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
Globenewswire· 2025-11-28 12:01
Core Insights - AbbVie has announced two positive updates for Canadians living with ulcerative colitis (UC) [1] - Canada's Drug Agency (CDA-AMC) has recommended SKYRIZI (risankizumab) for reimbursement under specific conditions for adults with moderately to severely active UC [2][3] - AbbVie has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI for UC, resulting in a signed Letter of Intent (LOI) [3][5] Summary by Sections Treatment Recommendations - The CDA-AMC's recommendation for SKYRIZI is based on feedback from 25 Canadian clinicians and two patient organizations, ensuring patient perspectives were included [3] - SKYRIZI is indicated for adults with UC who have had inadequate responses to conventional therapies, biologic treatments, or Janus kinase (JAK) inhibitors [8] Clinical Evidence - The positive recommendations for SKYRIZI were supported by evidence from pivotal phase 3 clinical trials, including MOTIVATE, ADVANCE, FORTIFY (for Crohn's disease), and INSPIRE, COMMAND (for UC) [5] Patient Impact - The introduction of SKYRIZI is seen as a significant step towards providing effective treatment options for UC patients, which can help improve their quality of life and long-term health outcomes [5][6] - Approximately 120,000 Canadians are estimated to live with UC, highlighting the need for effective treatment options [7] Company Commitment - AbbVie expresses commitment to improving patient access to innovative medicines for inflammatory bowel disease through collaboration with health authorities [6]