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Eli Lilly's Omvoh granted FDA approval to treat Crohn's disease in adults - PMLiVE
A new FDA-approved treatment option is now available for adults with moderately to severely active Crohn’s disease, including people who’ve not responded to or tolerated prior therapies. Approval was supported by phase 3 clinical trial evidence showing improved remission and intestinal healing versus placebo.
Adults with moderately to severely active Crohn’s disease, patients who have failed or intolerant to steroids/immunomodulators/biologics, clinicians treating IBD, and researchers following IL-23 targeted therapies.
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 and supporting open-label data from VIVID-2. Omvoh is already approved for ulcerative colitis and works by targeting the interleukin-23 p19 subunit (an IL-23 inhibitor).
The FDA decision expands an existing IBD indication for mirikizumab into Crohn’s disease. The VIVID-1 trial met both primary endpoints, with higher rates of clinical remission and endoscopic healing at one year versus placebo, and VIVID-2 open-label data show sustained responses with longer treatment.
The article notes the drug was studied in patients who had inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators or biologics.
Regulatory context: The EMA’s human medicines committee recently recommended mirikizumab for Crohn’s disease and the European Commission will consider that recommendation; the US approval follows the FDA review. Next steps for patients: This is a regulatory approval announcement, not treatment guidance.
Patients should discuss options with their clinicians to understand whether mirikizumab is appropriate for their individual history and prior treatments.
This article reports a regulatory approval based on the VIVID-1 and VIVID-2 studies; it does not provide full prescribing details, long-term safety data, or comparative effectiveness versus other available therapies. Treatment decisions should be based on detailed trial data and clinician judgment.
