Omvoh FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 31, 2023.
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
Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults.
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by inflammation and ulcers on the inner lining of the large intestine. The inflammation in UC is thought to be caused in part by overactivation of the interleukin-23 (IL-23) pathway.
- Omvoh contains mirikizumab-mrkz, which works to reduce inflammation in ulcerative colitis by selectively targeting the p19 subunit of IL-23 to inhibit the IL-23 pathway.
- FDA approval of Omvoh 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).
- Omvoh is administered by intravenous infusion over at least 30 minutes in the induction period at Weeks 0, 4, and 8, then by subcutaneous injection in the maintenance period at 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 during the induction period include upper respiratory tract infections and arthralgia.
Common adverse reactions during the maintenance period include upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
Development timeline for Omvoh
Further information
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