US EditionLilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis
The FDA approved a single monthly injection of Omvoh, simplifying maintenance therapy for ulcerative colitis with bioequivalent efficacy to the previous two-injection regimen.
- On Oct. 27, 2025, the U.S. Food and Drug Administration approved a single-injection, once-monthly Omvoh maintenance regimen for adults with moderately to severely active ulcerative colitis in the United States.
- Based on bioequivalence data, regulators accepted that one 200 mg/2 mL subcutaneous injection is equivalent to two 100 mg/1 mL injections, with treatment starting as three 300-mg IV infusions before Week 12.
- Quoting a gastroenterologist, `In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience`, Miguel Regueiro said, as Omvoh's single monthly injection maintenance regimen replaces the previous two-injection regimen.
- Lilly Support Services offers co-pay assistance for eligible, commercially insured patients and provides maintenance dosing via prefilled pen or prefilled syringe with home-injection training.
- This approval marks the third FDA nod this year for mirikizumab-mrkz and follows European Union authorization, with Lilly including forward-looking statements warning of serious allergic reactions and infections.
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The Courier-Tribune
Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis
Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two-injection regimen
Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis (2025-10-27)
-Eli Lilly and Company announced today that the U.S. Food and Drug Administration approved a single-injection, once-monthly maintenance regimen of Omvoh for subcutaneous use in adults with moderately to severely active ulcerative colitis. The Omvoh single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or...
FDA approves once-monthly Omvoh injection as maintenance for ulcerative colitis
The FDA has approved a once-monthly injection of Eli Lilly’s Omvoh for maintenance therapy in adult patients with moderately to severely active ulcerative colitis, supplanting its previous two-injection regimen.This approval marks the third FDA approval for mirikizumab-mrkz (Omvoh, Lilly) this year, following its earlier approvals for Crohn’s disease and a citrate-free formulation.
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U.S. FDA approves Eli Lilly’s single-injection, once-monthly Omvoh regimen for adults with ulcerative colitis
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-certifie…
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