Health Canada Expands Eli Lilly's Omvoh Indication to Crohn's and Approves Citrate-Free Formula.

Health Canada has expanded Eli Lilly's Omvoh indication to include treatment for Crohn's disease. The agency has also approved a citrate-free formula for the medication. Eli Lilly is a leading pharmaceutical company with a global presence, with net sales distributed across various therapeutic fields and geographic regions.

Health Canada has expanded the indication for Eli Lilly's Omvoh (mirikizumab) to include treatment for Crohn's disease (CD), marking a significant milestone in the management of inflammatory bowel disease (IBD). The regulatory approval, announced on July 15, 2025, comes after the drug demonstrated statistically significant and clinically meaningful efficacy in a Phase 3 clinical trial, VIVID-1 [1].

Omvoh, an interleukin-23p19 antagonist, is now indicated for both major forms of IBD—ulcerative colitis (UC) and CD. The new approval follows the successful completion of the VIVID-1 study, which enrolled over 1,000 adults with moderately to severely active CD. The study showed that mirikizumab met coprimary composite endpoints and all major secondary endpoints, including patient-reported clinical response and endoscopic response, compared to placebo [1].

In addition to the new CD indication, Health Canada has also approved a citrate-free formulation of Omvoh for subcutaneous injection. This formulation contains the same active ingredients as the original Omvoh and is intended to improve patient experience while maintaining the drug's efficacy and safety profile [1].

The approval of Omvoh for CD is seen as a positive development by patient advocacy groups and healthcare professionals. Sylvain Chiasson, Interim President & CEO of Crohn's and Colitis Canada, noted that the new therapy offers hope for people with CD, who often face challenges with available treatments [1]. Gail Attara, Chief Executive Officer of the Gastrointestinal Society, echoed this sentiment, highlighting the limited medication options for CD and the importance of Omvoh's expanded use [1].

Eli Lilly, a global pharmaceutical company, has a long history of innovation in the healthcare sector. With this latest approval, the company continues to demonstrate its commitment to addressing complex health challenges, including IBD. Omvoh's success in clinical trials and regulatory approvals underscores the potential of targeted therapies in managing chronic inflammatory conditions [1].

References:
[1] https://finance.yahoo.com/news/health-canada-approves-lillys-omvoh-123000416.html
[2] https://seekingalpha.com/news/4467453-eli-lillys-omvoh-wins-health-canada-approval-for-crohns-disease
[3] https://www.moomoo.com/news/post/61817796/record-tr4cking-news-default