Eli Lilly Omvoh secures USFDA approval as single-injection maintenance regimen in adults with ulcerative colitis

Eli Lilly's Omvoh Secures USFDA Approval

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a single-injection, once-monthly maintenance regimen 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.

Author's summary: Eli Lilly's Omvoh gets FDA approval.

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Medical Dialogues Medical Dialogues — 2025-10-28

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