Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved a new single-injection, once-monthly maintenance option (200 mg/2 mL) for Omvoh (mirikizumab-mrkz), designed 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., a 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 citrate-free, single-injection formulation of Omvoh will be made available in the United States by early 2026 through either a prefilled pen or prefilled syringe. The U.S. decision comes shortly after the European Union’s authorization of Omvoh for the same single-injection maintenance use in ulcerative colitis patients.
“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 the 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 FDA’s approval follows a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in patients. The study established that the single-injection dose is bioequivalent to the earlier two-injection regimen. Treatment with Omvoh begins with three 300-mg IV infusions given every four weeks before transitioning to a subcutaneous self-injection every four weeks at Week 12 for ongoing maintenance.
“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 currently approved in the United States for treating moderately to severely active ulcerative colitis and Crohn’s disease in adults, and it has received regulatory approval in 45 countries worldwide. Lilly also offers patient assistance through Lilly Support Services™, including co-pay support for eligible, commercially insured patients.
