Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely-active Crohn's disease, an inflammatory bowel disease that causes chronic abdominal pain.
The treatment, developed by the pharmaceutical company under the brand name Omvoh, is now approved to treat two types of inflammatory bowel disease in the U.S., the Indianapolis company said Wednesday. The drug was previously approved to treat ulcerative colitis in adults in October 2023.
Omvoh's approval as a treatment for Crohn's disease was based on results from a study in which 53% of patients treated with the drug achieved clinical remission, and 46% of patients had visible healing of the intestinal lining, at one year.
The therapy works to reduce inflammation within the gastrointestinal tract by targeting a specific protein that is a key contributor to intestinal inflammation, Eli Lilly said. It added it has submitted marketing applications for Omvoh in Crohn's disease around the globe, including in the European Union and Japan.
Chief Executive Michael Osso said Crohn's disease places a substantial burden on patients' daily lives. "This approval is meaningful for adult patients with Crohn's disease, who now have more treatment options available," he said.
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