Skip to main content

FDA Approves Omvoh for Moderately to Severely Active Crohn Disease

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 17, 2025.

By Elana Gotkine HealthDay Reporter

THURSDAY, Jan. 16, 2025 -- The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company.

Omvoh targets interleukin-23p19, which contributes to intestinal inflammation. Omvoh is the first biological treatment for Crohn disease to have disclosed two-year phase 3 efficacy data at the time of approval in more than 15 years.

The approval is based on results of the phase 3 VIVID-1 study in adults with moderately to severely active Crohn disease with inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics. Patients were randomly assigned to placebo or Omvoh; those in the placebo group who did not achieve clinical response at 12 weeks were switched to Omvoh treatment. Both primary end points were achieved; clinical remission at one year was achieved by 53 and 36 percent of patients treated with Omvoh and placebo, respectively, and visible healing of the intestinal lining at one year occurred in 46 and 23 percent of patients treated with Omvoh and placebo, respectively.

"With Omvoh approved in both Crohn's disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly's ongoing commitment to elevate care and improve outcomes for patients," Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, said in a statement.

Approval of Omvoh was granted to Eli Lilly.

Mote Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Read this next

Nebraska First State to Ban Soda, Energy Drinks From SNAP Program

WEDNESDAY, May 21, 2025 — Nebraska is the first state to get federal approval to ban the purchase of soda and energy drinks under the Supplemental Nutrition Assistance...

Deaths Waiting For Lung Donation Have Dropped Under New Guidelines

WEDNESDAY, May 21, 2025 — New guidelines for allocating donated lungs are saving more lives, a new study says. By prioritizing medical urgency, the guidelines caused a...

9 In 10 U.S. Teens Have Been Cyberbullied

WEDNESDAY, May 21, 2025 -- Cyberbullying is widespread among U.S. teens and is linked to post-traumatic stress symptoms in middle- and high-school students, a new study...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.