FDA approves Omvoh (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis – Eli Lilly

Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/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.

“I see many people with ulcerative colitis who previously tried other biologic treatments, and they are still searching for an effective option that can offer rapid and lasting improvements,” said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. “Today’s approval represents a novel scientific advancement, providing a treatment that may offer relief from three key symptoms—stool frequency, rectal bleeding and bowel urgency—regardless of past biologic use.”

The approval was based on results from the LUCENT program , which included two randomized, double-blind, placebo-controlled Phase III 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.

After 12 weeks of treatment with Omvoh, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, Omvoh demonstrated consistent efficacy across subgroups, with 51% of all patients and 45% of patients who failed prior treatment with a biologic or Janus kinase inhibitor (JAKi) achieving clinical remission at one year compared to placebo (27% and 15%, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, nearly all patients (99%) who achieved clinical remission at one year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least three months prior to the end of the 52-week assessment. Among those who achieved clinical remission at 12 weeks, approximately two-thirds (66%) of patients maintained clinical remission through one year of continuous treatment compared to placebo (40%).