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FDA approves Mirikizumab-mrkz for Crohn’s disease
This gives adults with moderately to severely active Crohn’s disease another FDA‑approved biologic option, including for people who did not respond to or could not tolerate other therapies.
The approval is supported by Phase 3 trial data showing clinical remission and endoscopic healing at one year and maintenance in many patients through two years.
Adults with moderately to severely active Crohn’s disease, patients who have failed or not tolerated prior immunomodulators or biologics, gastroenterologists and other clinicians who treat IBD, and researchers following new IBD therapies.
What To Know
FDA approval: The U.S. FDA has approved Mirikizumab-mrkz for adults with moderately to severely active Crohn’s disease. This approval is based on positive Phase 3 VIVID-1 trial results showing improvements in clinical remission and endoscopic response at one year, with many patients maintaining benefit through two years in extension data.
What to know about the drug: Mirikizumab-mrkz is a biologic that targets the IL-23p19 protein (an IL-23 inhibitor). The reported trial enrolled patients who had inadequate response, loss of response, or intolerance to steroids, immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) and/or biologics (TNF blockers and integrin receptor antagonists).
Common adverse reactions reported included upper respiratory infections, injection-site reactions, headache, arthralgia and elevated liver tests; the label includes warnings about hypersensitivity, infection risk including tuberculosis, hepatotoxicity and immunizations.
Access and coverage: Eli Lilly (manufacturer) says it is working with insurers and health systems to enable access; the press release notes some pharmacy benefit managers have given first-line biologic coverage and Lilly offers patient support programs and copay assistance where eligible.
This is a regulatory/press-release summary of FDA approval and trial results reported by the sponsor. While Phase 3 results and extension data are described, the full prescribing information and peer‑reviewed publications should be consulted for detailed safety and efficacy data. Approval in other countries is pending and ongoing studies (VIVID-2 OLE) are continuing.
