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FDA Approves Omvoh for Moderately to Severely Active Crohn Disease
This approval adds a newly authorized biologic option (mirikizumab/Omvoh) for adults with moderate-to-severe Crohn disease, including people who have not done well on steroids, immunomodulators, or prior biologics.
The drug’s reported one-year remission and healing results suggest it may help some patients achieve longer-term disease control.
Adults with moderately to severely active Crohn disease; people who have had inadequate response or intolerance to corticosteroids, immunomodulators, or biologics; clinicians who treat IBD; researchers following new IBD therapies.
What To Know
FDA approved Omvoh (mirikizumab-mrkz) for adults with moderately to severely active Crohn disease based on phase 3 VIVID-1 results showing higher rates of clinical remission and endoscopic healing at one year versus placebo.
The drug targets the IL-23 p19 pathway and is noted as the first biologic for Crohn’s with disclosed two-year phase 3 efficacy data in over 15 years. Approval was granted to Eli Lilly.
The article summarizes a press release and FDA approval based on the phase 3 VIVID-1 trial; it reports one-year outcomes and mentions two-year data disclosure but does not provide full trial details here.
This is a regulatory approval announcement, not treatment guidance—discussions with a treating clinician are needed to understand if Omvoh is appropriate for an individual patient.
