FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company has announced today that the U.S. Food and Drug Administration
(FDA) has approved Omvoh™ (mirikizumab-mrkz) (infusion300 mg/15 mL)/injection (100mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Marking a significant milestone, 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 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.
Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
Omvoh will be available in the United States in the coming weeks. Lilly received approval for Omvoh in Japan and the European Union this year and expects regulatory decisions in additional markets around the world in the coming months.
