Omvoh FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 16, 2025.
FDA Approved: Yes (First approved October 26, 2023)
Brand name: Omvoh
Generic name: mirikizumab-mrkz
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Ulcerative Colitis, Crohn's Disease
Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist used for the treatment of ulcerative colitis and Crohn’s disease.
- Omvoh is indicated for the treatment of:
- moderately to severely active ulcerative colitis in adults
- moderately to severely active Crohn’s disease in adults. - Ulcerative colitis and Crohn’s disease are inflammatory bowel diseases.
- Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation.
- FDA approval of Omvoh in the treatment of ulcerative colitis was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. After 12 weeks of treatment with Omvoh, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively).
- FDA approval of Omvoh in the treatment of Crohn’s disease was based on results from the randomized placebo-controlled Phase 3 VIVID-1 study. At one year, 53% of patients treated with Omvoh achieved clinical remission compared to 36% on placebo, and 46% of patients treated with Omvoh had an endoscopic response (visible healing of the intestinal lining) compared to 23% on placebo. In the trial, patients who were randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks (40% of placebo patients) were subsequently switched to Omvoh treatment.
- - In ulcerative colitis patients, Omvoh is administered by intravenous infusion over at least 30 minutes in the induction period (Week 0, Week 4, and Week 8) and by subcutaneous injection in the maintenance period (Week 12 and every 4 weeks thereafter).
- In Crohn’s disease patients, Omvoh is administered by intravenous infusion over at least 90 minutes in the induction period (Week 0, Week 4, and Week 8) and by subcutaneous injection in the maintenance period (Week 12 and every 4 weeks thereafter). - Warnings and precautions associated with Omvoh include hypersensitivity reactions, increased risk of infection, and hepatotoxicity. Omvoh should not be administered to patients with active tuberculosis. Use of live vaccines should be avoided.
- Common adverse reactions in ulcerative colitis patients during the induction period include upper respiratory tract infections and arthralgia; and during the maintenance period include upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
Common adverse reactions in Crohn’s disease patients include upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.
Development timeline for Omvoh
Further information
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