Global pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for 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).

The single-injection, citrate-free maintenance dose will be offered in the United States through prefilled pen or prefilled syringe from early 2026.

This approval follows Omvoh's recent European Union authorisation for single-injection maintenance dosing for UC.

A Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in patients confirmed that the product is bioequivalent to the earlier approved two-injection regimen.