FDA Approves Lilly’s Omvoh for Crohn's Disease, Second Indication

Crohn's disease © eddows - stock.adobe.com

The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment of moderate to severe active Crohn's disease in adults according to a recent news release. This is its second indication. In 2023, it was approved as a first-in-class treatment for moderate to severe ulcerative colitis in adults.

This approval is based on the results of the phase 3 VIVID-1 study of Omvoh in adult patients with moderate to severe Crohn’s disease with symptoms unresponsive to corticosteroids, immunomodulators and/or biologics.

About 1 million people in the United States have Crohn’s disease. It often develops gradually with symptoms such as diarrhea, abdominal pain and weight loss, called flares, that may get worse over time, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The goal of treatment is to have symptoms to go into remission long term.

Omvoh reduces gastrointestinal tract inflammation by targeting the interleukin-23p19 protein, a main contributor to the inflammation that causes symptoms. For the Crohn’s disease indication, 900 mg of Omvoh is given intravenously every four weeks. At week 12, patients will switch to a 300 mg subcutaneous injection, every four weeks. Omvoh should be refrigerated and brought to room temperature before use.

At one year, more than half (53%) of patients reached clinical remission, versus 36% on placebo, measured at one year, defined as a Crohn's Disease Activity Index score less than 150. Additionally, 46% of patients had visible healing of the intestinal tract versus 23% on placebo.

The most common adverse reactions reported were upper respiratory tract infections (28%), injection site reactions (10%) and headaches (6%).

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

Omvoh is currently being studied in VIVID-2, an ongoing, open-label extension evaluating the safety and efficacy of Omvoh for up to three years in patients. So far nearly 90% of patients have maintained remission and more than 80% have maintained endoscopic healing, with two years of continuous treatment.