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Eli Lilly’s Omvoh granted FDA approval to treat Crohn’s disease in adults
This gives adults with moderately to severely active Crohn’s disease an additional FDA-approved biologic option that targets the IL-23 pathway. Approval was supported by late-stage trial results showing improvements in clinical remission and endoscopic healing at one year.
Adults with moderately to severely active Crohn’s disease, patients who previously had inadequate response or intolerance to corticosteroids, immunomodulators or biologics, gastroenterologists, and IBD researchers.
What To Know
The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz/mirikizumab) for adults with moderately to severely active Crohn’s disease based on positive results from the Phase 3 VIVID-1 trial.
The approval follows earlier US approval of Omvoh for moderately to severely active ulcerative colitis and a recent positive recommendation from the EMA committee for Crohn’s disease.
VIVID-1 met its primary endpoints including clinical remission and endoscopic healing at one year versus placebo, and an open-label extension (VIVID-2) has reported sustained responses with additional treatment. The drug targets the interleukin-23 p19 subunit (IL-23 p19), an immune pathway involved in gut inflammation.
What this report does not provide are full trial protocols, detailed safety results, or prescribing information — consult official FDA labeling and your treating clinician for how this might apply to individual care.
Regulatory approval is based on VIVID-1 and supporting extension data; the article summarizes trial-level outcomes but does not include full safety tables or prescribing details. Decisions about treatment choice or switching should be made with a clinician using the official FDA label and individual patient factors.
