Omvoh (mirikizumab-mrkz) approved by FDA as a single-injection maintenance regimen in adults with ulcerative colitis – Eli Lilly

Eli Lilly and Company announced that the FDA 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 Omvoh single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026. The U.S. approval follows the recent European Union authorization of Omvoh for single-injection maintenance dosing for UC.

“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 single-injection approval is based on results from a Phase I study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in participants. The study confirmed that Omvoh single-injection is bioequivalent to the previously approved two-injection regimen. Treatment with Omvoh for ulcerative colitis starts with 300-mg IV infusions every four weeks, for a total of three infusions, and at Week 12 transitions to subcutaneous self-injection every four weeks for maintenance treatment.

“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.”