FDA Approves Lilly's First-in-Class IL-23p19 Antagonist Omvoh (mirikizumab) for Moderately to Severely Active Ulcerative Colitis in Adults

Oct 27, 2023 08:28 CST Updated 08:28

Eli Lilly

Global Pharmaceutical R&D and Production Company

▎WuXiEdited by Kant Content Team

Eli Lilly and Company announced today,The U.S. FDA has approved Omvoh (mirikizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).The press release pointed out that this isThe first IL-23p19 antagonist for the treatment of this patient population。

UC is a disease caused by chronic inflammation of the large intestine. It triggers abdominal pain, bloody diarrhea, severe urgency to defecate, weight loss, and fatigue. The severity of symptoms and the uncertainty of disease recurrence place a heavy burden on patients and often lead to disability. Millions of people worldwide are affected by UC.

Mirikizumab, developed by Eli Lilly and Company, is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, blocking IL-23-mediated inflammatory responses.

The FDA approval was based on the results of the LUCENT clinical program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials: a 12-week induction treatment study (UC-1) and a 40-week maintenance treatment study (UC-2). All patients in the LUCENT program had previously received treatment, including biologic therapies, but did not achieve efficacy, lost efficacy, or were intolerant.

The test results showed,After 12 weeks of Omvoh treatment, 65% of patients achieved clinical response, and 24% of patients achieved clinical remission.The clinical response and clinical remission rates in the placebo group were 43% and 15%, respectively.Among patients who achieved clinical remission at 12 weeks, 66% maintained clinical remission during one year of continuous treatment., the value in the placebo group was 40%. According to post-hoc analysis,Almost all (99%) patients who achieved clinical remission at 1 year were steroid-free for at least 3 months prior to the end of the 52-week assessment.

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References:

[1] FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved October 26, 2023, from https://www.prnewswire.com/news-releases/fda-approves-lillys-omvoh-mirikizumab-mrkz-a-first-in-class-treatment-for-adults-with-moderately-to-severely-active-ulcerative-colitis-301969505.html

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