FDA Approves Simplified Monthly Injection for Lilly’s Omvoh in Ulcerative Colitis
Eli Lilly and Company has received U.S. Food and Drug Administration (FDA) approval for a new single-injection, once-monthly maintenance regimen of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis (UC). The 200 mg/2 mL subcutaneous dose replaces the previous two-injection regimen, offering patients a more convenient treatment option starting in early 2026. The approval marks the third FDA milestone for Omvoh this year, following earlier clearances for Crohn’s disease and a citrate-free formulation. The single-injection maintenance dose, administered via prefilled pen or syringe, will be available in the U.S. after an initial induction phase of three 300 mg intravenous infusions every four weeks. The simplified regimen follows similar authorization in the European Union. Clinical data from a Phase 1 study demonstrated that the single 200 mg injection is bioequivalent to the prior two 100 mg injections, delivering…
