SKYRIZI® (risankizumab) Now Available for Moderately to Severely Active Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease

• SKYRIZI is the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.¹

MONTREAL, March 4, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that SKYRIZI® (risankizumab) is now available in Canada for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor¹, following Health Canada approval of this indication in October 2024. SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases.

"We are so grateful for the approval of SKYRIZI for ulcerative colitis and hopeful it will have a positive effect on patient healing," said Gail Attara, CEO and co-founder of the Gastrointestinal Society. "Ulcerative colitis is a debilitating inflammatory bowel disease. Given the uniqueness of each individual, it's essential to bring new treatment options for ulcerative colitis, even though other products exist. This ensures that each person can receive the most suitable medication to effectively manage this incurable disease."

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that can lead to substantial burden and often disability among patients.^2,3 Canada has one of the highest rates of inflammatory bowel disease in the world, the two main forms of which are Crohn's disease and ulcerative colitis.⁴ More than 300,000 Canadians are living with IBD, and the rate of diagnosis is increasing amongst certain demographics including seniors.⁴

"There remains a significant unmet need in treating patients with moderate to severe ulcerative colitis. Risankizumab is gaining recognition as an effective treatment for UC, providing patients with a combination of efficacy, safety, and convenience," says Dr. Remo Panaccione, MD, Professor of Medicine and Director of the IBD unit, University of Calgary. "Clinical trials demonstrate many patients achieve long-term remission and endoscopic healing, a key indicator of sustained disease control. This is complemented by a consistent safety profile and dosing every 8 weeks (following 3 intravenous infusions at weeks 0, 4 and 8). When taken together this represents a significant advancement for patients living with ulcerative colitis."

"Living with ulcerative colitis meant pre-planning outings, locating washrooms, and carrying extra clothes in case of accidents. My world got smaller, choosing to stay at home rather than risk embarrassment in public," shared Melanie D., from Edmonton, Alberta. "With SKYRIZI, I feel so much better, both physically and mentally, alleviating my worries about washroom access and allowing me to travel with confidence, feeling healthy and assured in public."

"With the high prevalence of IBD in Canada, AbbVie recognizes the need for more treatment options for people living with this debilitating disease," stated Rami Fayed, Vice President and General Manager of AbbVie Canada. "The SKYRIZI indication for ulcerative colitis demonstrates our ongoing commitment to patients across Canada."

About SKYRIZI^® (risankizumab)¹
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including ulcerative colitis. SKYRIZI is also approved in Canada for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies.

For important safety information, please consult the SKYRIZI Product Monograph at www.abbvie.ca.

About AbbVie in Gastroenterology
AbbVie has focused on improving care in gastroenterology for more than 10 years. With a robust clinical trial program in inflammatory bowel disease (IBD), we are committed to cutting-edge research to drive new discoveries and developments in Crohn's disease and ulcerative colitis. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact in the lives of people with IBD.

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. Follow AbbVie Canada on X, on Instagram or find us on LinkedIn.

References

^1	SKYRIZI (risankizumab) product monograph. AbbVie Corporation. Available at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf Accessed March 2025.
^2	Gajendran M., et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2.
^3	Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
^4	Crohn's and Colitis Canada 2023 Impact of Inflammatory Bowel Disease in Canada. Available at: https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2023-IBD-Report-English-LR.pdf?ext=.pdf. Accessed March 2025.

SOURCE AbbVie Canada

Media: Dominique Touchette, AbbVie Canada, 438-821-3971, [email protected]