FDA Approves Mirikizumab for Crohn Disease: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On January 15, 2025, we reported on on the US FDA approval of mirikizumab-mrkz (Omvoh, Eli Lilly) for the treatment of moderately to severely active Crohn disease (CD) in adults.

The approval

Mirikizumab is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in CD at the time of approval. Mirikizumab works by targeting a specific protein, interleukin-23p19 (IL-23p19), which is involved in intestinal inflammation.

The FDA approval is based on data from the Phase 3 VIVID-1 trial, which demonstrated that 53% of patients treated with Omvoh achieved clinical remission at one year compared to 36% of those receiving placebo. Additionally, 46% of mirikizumab-treated patients showed endoscopic response at one year versus 23% on placebo. An ongoing open-label extension study, VIVID-2, indicated that nearly 90% of patients who achieved both clinical remission and endoscopic response at one year maintained clinical remission with two years of continuous Omvoh treatment.

In terms of safety profile for CD, the most common adverse events included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver enzymes, generally consistent with the safety profile for treatment for UC. The FDA label includes warnings for hypersensitivity reactions, infections, tuberculosis, hepatotoxicity, and immunizations.

In addition to FDA approval, mirikizumab has been submitted for regulatory review for CD around the globe, including in the European Union and Japan.

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