FDA Approves Omvoh for Moderately to Severely Active Crohn Disease
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.
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.
Posted January 2025
Read this next
FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews
WEDNESDAY, June 11, 2025 — The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of new drugs and medical...
These Smiling Salamanders Are Helping Scientists Learn to Regrow Limbs
WEDNESDAY, June 11, 2025 — With their goofy grins and feathery gills, axolotls have become stars of the pet world and video games like Minecraft. But these small...
Real-World Results For GLP-1 Drugs Underwhelm, Study Says
WEDNESDAY, June 11, 2025 — Real-world results for blockbuster weight-loss meds like Ozempic, Wegovy and Zepbound aren’t as impressive as those promised by the...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.