healio.com
IBD drug market rattles as Lilly’s Omvoh nabs FDA approval for second IL-23p19 in Crohn’s
A new FDA approval means another biologic option for people with moderately to severely active Crohn’s disease, including patients who have failed or not tolerated prior therapies.
More IL‑23p19 drugs entering the market could affect treatment choices, insurance coverage, and potentially pricing or sequencing of biologics.
Adults with Crohn’s disease, patients who have tried or are considering biologics, IBD clinicians, and researchers following IL‑23 targeted therapies.
What To Know
The FDA approved Omvoh (mirikizumab‑mrkz) for moderately to severely active Crohn’s disease based on data from the 52‑week phase 3 VIVID‑1 trial and ongoing VIVID‑2 extension results.
Healio reports this makes mirikizumab the second IL‑23p19–specific inhibitor approved for both major IBD types, joining risankizumab (Skyrizi) and alongside IL‑12/23 inhibitor ustekinumab; guselkumab (Tremfya) is awaiting approval for Crohn’s disease.
Trial results cited include higher rates of 1‑year clinical remission and endoscopic response with Omvoh versus placebo, and safety findings similar to its ulcerative colitis experience with listed common adverse reactions and label warnings.
This is a regulatory approval story based on phase 3 trial results (VIVID‑1) and extension data (VIVID‑2) reported by the sponsor and Healio. The article summarizes trial endpoints (clinical remission by CDAI, endoscopic response) and safety signals but does not replace reading the original FDA label or peer‑reviewed publications.
Real‑world effectiveness, head‑to‑head comparisons among IL‑23 agents, long‑term safety, and effects on cost and access remain to be fully established.
