AbbVie Inc. (ABBV) announced Friday that it's scored two important regulatory wins in Canada for Skyrizi, its blockbuster drug now approved to treat ulcerative colitis. The updates bring the company closer to making the treatment accessible to Canadian patients dealing with this chronic inflammatory bowel disease.
First, some context: Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that targets the large intestine. It causes persistent inflammation and ulceration of the colon's lining, leading to symptoms like frequent diarrhea, abdominal pain, and rectal bleeding. It's one of those conditions where treatment options matter tremendously for quality of life.
Skyrizi (risankizumab) works as an IL-23 inhibitor, and it's been on quite a roll in Canada lately. The drug just received its second consecutive positive reimbursement recommendation from Canada's Drug Agency for inflammatory bowel diseases—first for Crohn's disease, and now for ulcerative colitis. These recommendations are backed by solid evidence from pivotal phase 3 clinical trials, including MOTIVATE, ADVANCE, and FORTIFY for Crohn's disease, plus INSPIRE and COMMAND for ulcerative colitis.
Here's what the recommendation means in practical terms: Canada's Drug Agency is advising that public drug plans should reimburse Skyrizi (with certain conditions) for adults with moderately to severely active ulcerative colitis. The catch? Patients need to have already tried and failed conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor. The recommendation came after gathering feedback from 25 Canadian clinicians and two patient organizations, so there was real-world input baked into the decision.
The second piece of news is equally important: AbbVie has wrapped up negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding Skyrizi for ulcerative colitis, and both parties have signed a Letter of Intent. This is the pricing agreement that makes reimbursement actually happen, so it's a crucial step toward getting the drug into patients' hands.
For AbbVie, Skyrizi has become a genuine blockbuster. In the third quarter of 2025, Skyrizi sales jumped 46.8% year over year to $4.71 billion. That kind of growth explains why the company is working so hard to expand access in markets like Canada.










