Eli Lilly secured U.S. Food and Drug Administration approval for a single‑injection, once‑monthly maintenance regimen of Omvoh (mirikizumab‑mrkz) for adults with moderately to severely active ulcerative colitis. The new regimen delivers 200 mg of the drug in a 2 mL subcutaneous injection, replacing the previously required two‑injection schedule of 100 mg each.
Omvoh was first approved for ulcerative colitis on October 26, 2023, and for Crohn’s disease in January 2025. The single‑injection approval is the third FDA approval for the drug in 2025, following the Crohn’s disease approval and a citrate‑free formulation approval.
The approval was based on a Phase 1 bioequivalence study that demonstrated a single 200 mg/2 mL subcutaneous injection provides the same therapeutic exposure as two 100 mg/1 mL injections. The drug is an interleukin‑23p19 antagonist that targets a key inflammatory pathway in ulcerative colitis.
The new regimen will be available in the United States in early 2026. It follows a three‑infusion induction phase (300 mg IV at weeks 0, 4, and 8) before transitioning to the monthly subcutaneous maintenance injections.
The U.S. approval follows a recent European Union authorization for the same single‑injection maintenance dosing for ulcerative colitis, underscoring the global acceptance of the simplified dosing schedule.
The simplified dosing schedule is expected to improve patient adherence and satisfaction, potentially expanding Lilly’s market share in the competitive inflammatory bowel disease market.
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