FDA Approves Eli Lilly’s Omvoh for Crohn Disease

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The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for moderately to severely active Crohn disease in adults, marking the medication’s second FDA approval for inflammatory bowel disease following its previous approval for ulcerative colitis. According to the company, Omvoh is the first biologic drug in over 15 years to provide the FDA with two-year Phase III efficacy data at approval. The regulatory action was based on data from the VIVID-1 study, which demonstrated significant clinical remission and endoscopic response rates compared to placebo after one year.¹

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

For the randomized, double-blind, placebo-controlled 52-week VIVID-1 trial, patients were administered intravenous mirikizumab at a dose of 900 mg at weeks zero, four, and eight. After dosing, patients received a maintenance dose of 300 mg by subcutaneous injection at week 12 and every four weeks afterwards for a total of 40 weeks. The dual primary endpoints of the study were clinical remission by Crohn's Disease Activity Index at one year and endoscopic response at one year.

Results show that 53% of patients treated with Omvoh achieved clinical remission at one year compared to 36% in the placebo group. Additionally, 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year compared to the placebo group. Thirty-two percent of patients treated with Omvoh also achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, compared to 11% in the placebo group.

Omvoh is also being evaluated in the ongoing, open-label extension VIVID-2 study, which is evaluating the safety and efficacy of Omvoh for a maximum of three years.

In terms of safety, in both VIVID-1 and VIVID-2, the profile of Omvoh was found to be consistent with its previously established safety profile in patients with ulcerative colitis. Common adverse events included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.¹

"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," said Marla Dubinsky, MD, 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, in the press release. "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."

According to Medline Plus, Crohn disease is most common in western Europe and North America, with a prevalence of 100 to 300 per 100,000 people. While the cause of this trend is currently unknown, the prevalence of Crohn disease has been increasing in the United States and other parts of the world in recent years.²

"People living with Crohn's disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be," said Daniel M. Skovronsky, MD, PhD, chief scientific officer, president, Lilly Research Laboratories and Lilly Immunology, in the press release. "With Omvoh approved in both Crohn's disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly's ongoing commitment to elevate care and improve outcomes for patients."

References

1. FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease. Lilly. January 15, 2025. Accessed January 16, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease

2. Crohn's disease. Medline Plus. Accessed January 16, 2025. https://medlineplus.gov/genetics/condition/crohns-disease/#frequency