FDA Approves Lilly’s Mirikizumab-mrkz for Crohn’s Disease

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The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s mirikizumab-mrkz (mirikizumab) for the treatment of moderately to severely active Crohn’s disease (CD) in adults, according to a January 15, 2025, news release from Lilly.¹

The approval expands the indication for mirikizumab, to include the second major type of inflammatory bowel disease, following the October 2023 approval as first-in-class treatment for moderately to severely active ulcerative colitis (UC). Marketed as Omvoh, mirikizumab is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in CD at the time of approval, the news release said.¹

Mirikizumab works by targeting a specific protein, interleukin-23p19 (IL-23p19), which is involved in intestinal inflammation. The approval is based on data from the Phase 3 VIVID-1 trial, which demonstrated that 53% of patients treated with Omvoh achieved clinical remission at one year compared to 36% of those receiving placebo. Additionally, 46% of mirikizumab-treated patients showed endoscopic response at one year versus 23% on placebo. An ongoing open-label extension study, VIVID-2, indicated that nearly 90% of patients who achieved both clinical remission and endoscopic response at one year maintained clinical remission with two years of continuous Omvoh treatment.

In terms of safety profile for CD, the most common adverse events included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver enzymes, generally consistent with the safety profile for treatment for UC. The FDA label includes warnings for hypersensitivity reactions, infections, tuberculosis, hepatotoxicity, and immunizations.¹

Mirikizumab provides hope that patients with CD can achieve long-term remission even if other medication did not work, said Marla Dubinsky, M.D., chief, division of pediatric gastroenterology and nutrition, co-director, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine, Mount Sinai New York.

"Many patients with Crohn's disease have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease," Dubinsky said in the news release.¹

In addition to FDA approval, mirikizumab has been submitted for regulatory review for CD around the globe, including in the European Union and Japan.

Reference

1. FDA Approves Lilly’s Mirikizumab-mrkz for Crohn’s Disease.[news release]. January 15, 2025. Accessed January 15, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease