FDA Expands Approval of Mirikizumab to Crohn's Disease 

*Correction: "43% of patients treated with mirikizumab showed visible mucosal healing at one year vs 23% who received placebo" has been revised to accurately state "46% of patients treated with mirikizumab showed visible mucosal healing at one year vs 23% who received placebo".

The U.S. Food and Drug Administration (FDA) on January 16 approved mirikizumab-mrkz (Omvoh) for the treatment of moderately-to-severely active Crohn's disease in adults.

Mirikizumab was approved in October 2023 for treating moderately-to-severely active ulcerative colitis.

The agency based its approval on positive results from the Phase 3 VIVID-1 randomized, placebo-controlled trial study of mirikizumab in adults with moderately to severely active Crohn's disease. Participants in the trial had had inadequate response, loss of response, or intolerance to other therapies, including corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, tumor necrosis factor alpha blockers, and integrin receptor antagonists.

In the trial, 53% of patients treated with mirikizumab achieved clinical remission according to the Crohn's Disease Activity Index (CDAI) within one year, vs 36% of those who received placebo; 46% of patients treated with mirikizumab showed visible mucosal healing at one year vs 23% who received placebo.

VIVID-2, an ongoing, open-label extension study, is evaluating the efficacy and safety of mirikizumab for up to 3 years in adults with moderately to severely active Crohn's disease. Among patients who achieved endoscopic response at one year in VIVID-1, more than 80% maintained endoscopic response with one year of additional treatment. Of those who achieved both clinical remission and endoscopic response at one year in VIVID-1, nearly 90% maintained clinical remission with one year of additional treatment.

In both VIVID-1 and VIVID-2, the overall safety profile of mirikizumab in patients with moderately to severely active Crohn's disease was generally consistent with its known safety profile in patients with ulcerative colitis. The most common adverse reactions— reported in at least 5% of subjects through Week 52 of VIVID-1 were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests.

The labeling for mirikizumab contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity, and immunizations.

Mirikizumab is a product of Eli Lilly & Company.

Reference:

FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease. Press release. Eli Lilly & Company; January 16, 2025. Accessed January 16, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease