The FDA approved mirikizumab-mrkz (Omvoh) for adults with moderately to severely active Crohn's disease, marking its second indication following its October 2023 approval for ulcerative colitis. The interleukin-23p19 inhibitor demonstrated significant efficacy in achieving and maintaining clinical remission and endoscopic response through 2 years of treatment.

In the phase 3 VIVID-1 trial, 53% of mirikizumab-treated patients achieved clinical remission at 1 year compared with 36% in the placebo group. Endoscopic response was observed in 46% of treated patients versus 23% in the placebo group at 1 year. Early endoscopic response at 3 months was achieved in 32% of treated patients compared with 11% in the placebo group.

The VIVID-2 open-label extension study demonstrated sustained efficacy, with more than 80% of patients maintaining endoscopic response through 2 years of continuous treatment. Among patients achieving both clinical remission and endoscopic response at year 1, nearly 90% maintained clinical remission through the second year of treatment.

"The burden of Crohn's disease on patients' daily lives is substantial," Michael Osso, president and chief executive officer of the Crohn's & Colitis Foundation, said in a press release from Eli Lilly and Company. "This approval is meaningful for adult patients with Crohn's disease, who now have more treatment options available."

The trial included patients who had inadequate response, loss of response, or intolerance to conventional therapies including corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and biologics (TNF blockers, integrin receptor antagonists).

Safety profile analysis revealed the most common adverse reactions (≥5% and higher than placebo) included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests. The prescribing information includes warnings regarding hypersensitivity reactions, infection risk, tuberculosis, hepatotoxicity, and immunizations.

"The FDA approval of Omvoh may help adults with Crohn's disease achieve long-term remission and visible healing of the intestinal lining, even if they have tried other medications that did not work or stopped working," Mount Sinai's Marla Dubinsky, MD, chief of pediatric gastroenterology and nutrition, noted.

Mirikizumab represents the first biologic treatment in over 15 years to include 2-year phase 3 efficacy data at the time of approval. The drug gained first-line biologic coverage from 2 of the 3 largest pharmacy benefit managers effective January 1, 2025.

The manufacturer submitted additional marketing applications globally, including in the European Union and Japan. For ulcerative colitis, mirikizumab has already received approval in 44 countries.

Reference: FDA approves Lilly's Omvoh (mirikizumab, MRKZ) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease [news release]. PR Newswire.