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 comparable efficacy with reduced administration burden. Patients transitioning to maintenance therapy at week 12 can now manage treatment with one injection every four weeks, addressing the challenges of living with the unpredictable symptoms of UC.
Omvoh, an interleukin-23p19 (IL-23p19) antagonist, targets inflammation central to inflammatory bowel disease by selectively inhibiting the IL-23 pathway. The drug is approved in the U.S. for both UC and Crohn’s disease in adults and has gained authorization in 45 countries worldwide. Lilly supports eligible patients through co-pay assistance programs.
The approval reinforces efforts to improve treatment adherence and quality of life for individuals with chronic gastrointestinal conditions, where complex regimens can complicate disease management. The single-injection option aims to integrate more seamlessly into patients’ daily routines while maintaining proven clinical outcomes.
