Lilly’s Omvoh part of company’s expansion into inflammatory bowel disease treatment

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Eli Lilly and Co.’s approval for Omvoh to treat moderate to severe Crohn’s disease in adults marks the Indianapolis company’s growing presence in the treatment of inflammatory bowel disease.

This month’s U.S. Food and Drug Administration approval of the medication for Crohn’s followed the FDA’s approval in October 2023 for Omvoh to treat moderately to severely active ulcerative colitis in adults.

Ulcerative colitis and Crohn’s disease cause inflammation in the digestive tract and can be painful and debilitating. The exact causes are not known, and treatments include medication and surgery.

Dr. Mark Genovese, senior vice president of Lilly Immunology development, said Omvoh offers patients with Crohn’s another option to deal with often severe symptoms, including abdominal pain, frequent bowel movements, rectal bleeding and bowel urgency.

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“Despite the fact that there’s been therapies on the market for Crohn’s disease and ulcerative colitis, there’s still large unmet need,” Genovese said. “Even in the best of scenarios, less than 50% of patients achieve a clinical remission, and many are unable to maintain that in the long term.”

The FDA approval was based on results from the Phase 3 trial that found 53% of patients treated with Omvoh achieved clinical remission at one year compared with 36% of a placebo group. What’s more, 46% of Omvoh-treated patients showed visible healing of intestinal lining at one year compared with 23% of those on the placebo.

Lilly said Omvoh, or mirikizumab-mrkz, works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation.

Gastrointestinal, or GI, diseases account for significant health care costs paid by U.S. employers.

Indianapolis-based health data analytics company Springbuk, in its Employee Health Trends 2025 report, said GI diseases were among the top three most costly condition groups for employers with inflammatory bowel disease being the main driver.

“Ulcerative colitis and Crohn’s disease are the main conditions which require specialty drug therapy,” according to the Springbuk report, which cited the expanded use of drugs including AbbVie’s Skyrizi.

Lilly also bought Massachusetts-based Morphic Holding Inc., a biopharmaceutical company focused on therapies for inflammatory bowel disease and other chronic diseases, in a $3.2 billion deal last year, another avenue to developing potential treatments.

Genovese said, “Specifically, we’re looking forward to seeing data from two Phase 2 studies that Morphic has been doing, one in ulcerative colitis and one in Crohn’s disease, to understand how an oral drug that approaches a target called alpha 4, beta 7 might perform for the treatment of inflammatory bowel diseases.”

The relief of treatment, Genovese said, can be life-changing for those with Crohn’s: “The ability not to have to spend your day wondering where the bathroom is, if you’re in a car ride, wondering whether or not you’re going to be able to make it from one location to the next, those are truly disruptive to the average life.”

Omvoh has gained first-line biologic coverage from two of the three largest U.S. pharmacy benefit managers. Lilly also said it submitted marketing applications globally including in Japan and the European Union.

Lilly is scheduled to report fourth-quarter and full-year 2024 results Feb. 6.

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