FDA

Omvoh now approved for Crohn’s disease

January 20, 2025

Brand name: Omvoh

Generic name: mirikizumab-mrkz

Manufacturer: Eli Lilly

Approval date: January 15, 2025

FDA approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults.

Mirikizumab is a monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits IL-23 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines. The drug was first approved for moderately to severe active ulcerative colitis in 2023.

Efficacy

According to a manufacturer press release, approval was based on data from the phase 3 VIVID-1 study (NCT03926130) involving adults with moderately to severely active Crohn's disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics. Both primary endpoints of the study were achieved:

• Clinical remission by Crohn’s Disease Activity Index (CDAI) at one year: 53% of Omvoh recipients achieved clinical remission at one year vs. 36% of placebo recipients (p < 0.001).
• Endoscopic response at one year: 46% of Omvoh recipients had visible healing of the intestinal lining at one year vs. 23% of placebo recipients (p < 0.001).

In addition, 32% of Omvoh patients achieved early improvement in endoscopic response vs. 11% of those on placebo at three months (p < 0.001).

Safety

The most common adverse reactions (≥5% of trial participants and at a higher frequency than placebo) associated with Omvoh treatment were upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Sources:

FDA approves Lilly’s Omvoh® (mirikizumab-mrkz) for Crohn’s disease, expanding its use to the second major type of inflammatory bowel disease. Eli Lilly and Company. 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease. Accessed January 17, 2025.

Omvoh. Package insert. Eli Lilly and Company; 2025. Accessed January 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s003lbl.pdf