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# Lilly’s Omvoh Wins Expanded Approval
- URL: https://www.fdaweb.com/lillys-omvoh-wins-expanded-approval/
- Published: 2025-01-15T12:00:00.000Z
- Updated: 2026-09-14T14:50:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158495

FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn’s disease in adults. Omvoh was originally approved 10/2023 as a first-in-class treatment for moderately to severely active ulcerative colitis in adults. The new approval is based on data from the Phase 3 VIVID-1 study where both primary endpoints were met: **(1)** 53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo, and **(2)** 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo, according to Lilly. Omvoh is said to target interleukin-23p19 to reduce inflammation within the gastrointestinal tract.