FDA approves Lilly’s Omvoh: A breakthrough for ulcerative colitis treatment

The U.S. Food and Drug Administration (FDA) has sanctioned Eli Lilly and Company’s Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), making it the pioneering IL-23p19 antagonist for treating moderate to severe ulcerative colitis in adults. This groundbreaking treatment is distinguished for targeting the p19 subunit of IL-23, a catalyst in UC-related inflammation.

An Innovative Step in Ulcerative Colitis Treatment

“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,” remarked Bruce Sands, M.D., M.S. “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.”

Results from the LUCENT Program

The LUCENT program’s findings, which incorporated two randomized Phase 3 clinical trials, played a pivotal role in securing the FDA’s endorsement. The trials, spanning a cumulative of 52 weeks of treatment, included patients previously unsatisfied with biologic treatments. Remarkably, Omvoh-treated patients displayed a 65% clinical response within 12 weeks, surpassing placebo outcomes.

FDA approves Lilly’s Omvoh for the treatment of ulcerative colitis. Photo courtesy of Momoneymoproblemz/Wikimedia Commons.

Bowel Urgency and Patient Experience

Highlighting the disruption caused by bowel urgency in ulcerative colitis patients, Michael Osso, president of Crohn’s & Colitis Foundation, expressed, “Today’s approval of Omvoh offers new hope for those who have tried other therapies and still find themselves making accommodations for the uncertainty of bowel urgency-related accidents and other symptoms associated with ulcerative colitis.”

Safety and Adverse Effects

Omvoh demonstrated a favorable safety profile, with fewer patients ceasing the treatment due to adverse effects compared to placebo. Common side effects encompassed upper respiratory infections, rashes, headaches, and herpes viral infections. Omvoh’s labeling also encompasses cautionary advisories pertaining to hypersensitivity reactions, infections, and immunizations.

Lilly’s Commitment to Innovation

Highlighting Eli Lilly’s dedication to innovative solutions, Patrik Jonsson stated, “Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation.” He further mentioned Omvoh’s availability in the U.S. in the upcoming weeks and its approvals in Japan and the European Union earlier this year.