The US Food and Drug Administration approved Omvoh (mirikizumab-mrkz) as a once-monthly single-injection maintenance therapy for adults with moderately to severely active ulcerative colitis, based on phase 1 data demonstrating bioequivalence to the previously approved two 100 mg injections. The new 200 mg/2 mL subcutaneous formulation, developed by Eli Lilly and Company, will be available in the US in early 2026.

Maintenance therapy with Omvoh follows induction with three 300 mg intravenous infusions administered every 4 weeks. Omvoh, an interleukin-23p19 (IL-23p19) antagonist, selectively targets the p19 subunit of IL-23, a cytokine involved in the inflammatory cascade underlying ulcerative colitis and Crohn's disease.

According to Miguel Regueiro, MD, board-certified gastroenterologist specializing in inflammatory bowel disease, "In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience." This approval follows earlier 2025 US Food and Drug Administration approvals for Omvoh in Crohn’s disease and for a citrate-free formulation.

Omvoh is now approved in 45 countries for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Common adverse effects include upper respiratory infections, headache, joint pain, rash, and injection-site reactions. Clinicians are advised to monitor patients for infections and hepatic enzyme elevations during therapy, as Omvoh may increase susceptibility to infection and cause liver injury.

Source: Eli Lilly and Company