Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).
"In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience," said Miguel Regueiro, M.D., board-certified gastroenterologist specializing in inflammatory bowel disease. "A single monthly injection of Omvoh gives patients a regimen that's easier to manage alongside the unpredictability of living with ulcerative colitis."
The newly approved single-injection, citrate-free formulation will be available in the U.S. in early 2026 in both prefilled pen and syringe formats. This approval follows the European Union’s recent authorization of Omvoh for the same single-injection dosing regimen.
"People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives," said George Salem, M.D., director of Crohn's and Colitis Center at OU Health. "With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month — delivering the same proven results with fewer injections."
The approval is supported by results from a Phase 1 bioequivalence study comparing a single 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections, which confirmed pharmacokinetic equivalence between the two regimens. Omvoh treatment begins with 300-mg IV infusions every four weeks for 12 weeks, followed by monthly subcutaneous maintenance injections.
"At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience," said Ashley Diaz-Granados, senior vice president of U.S. Immunology at Lilly. "Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives."
Omvoh is approved in the U.S. for both ulcerative colitis and Crohn’s disease in adults and has received regulatory clearance in 45 countries worldwide. Through Lilly Support Services™, the company also offers co-pay assistance and patient support programs for eligible, commercially insured individuals.
