FDA approval for Lilly's Omvoh

Eli Lilly (NYSE: LLY) has announced that the US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) infusion (300mg/15 mL)/injection (100mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for moderately to severely active ulcerative colitis (UC) in adults.

Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.

The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase III trials. All patients in the program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.