FDA Approves Mirikizumab for Adults With Moderately to Severely Active Ulcerative Colitis

The U.S. Food and Drug Administration (FDA) approved mirikizumab-mrkz infusion for the treatment of moderately to severely active ulcerative colitis (UC) in adults, Eli Lilly and Company announced October 26.

Mirikizumab is the first and only interleukin-23p19 (IL-23p19) antagonist approved for UC to date.

The approval was based on results of the LUCENT program—2 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 were intolerant to, had not responded to, or had lost response to other therapies.

Mirikizumab achieved its primary and key secondary endpoints, including clinical remission at Week 12 and Week 52, and secondary endpoints of clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) at 12 weeks.

Following 12 weeks of treatment, 65% of patients treated with mirikizumab achieved clinical response and 24% achieved clinical remission compared to placebo. Among clinical responders at 12 weeks, 51% of all patients and 45% of patients who failed prior treatment with a biologic or Janus kinase (JAK) inhibitor achieved clinical remission at one year compared to placebo. A post-hoc analysis found that 99% who achieved clinical remission at 1 year with mirikizumab were steroid-free.

The LUCENT trials were the first and only to use the Urgency Numeric Rating Scale (NRS) of 0-10 to measure bowel urgency—one of the most challenging symptoms for patients with UC. Of atients with an average weekly Urgency NRS score ≥3 at baseline who responded to induction therapy with mirikizumab, 39% achieved a weekly average score of 0 to 1 at one year, compared to placebo (23%).

Patients treated with mirikizumab were less likely to discontinue treatment due to adverse events (1.6% in UC-1 and 1.5% in UC-2) compared to placebo (7.2% in UC-1 and 8.3% in UC-2). The most common adverse reactions were upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

Reference:

Eli Lilly and Company. FDA approves Lilly’s OmvohTM (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis. Eli Lilly and Company. October 26, 2023. Accessed October 27, 2023. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class