The US Food and Drug Administration has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults.

Omvoh targets interleukin-23p19, which contributes to intestinal inflammation. Omvoh is the first biological treatment for Crohn’s disease to have disclosed two-year Phase III efficacy data at the time of approval in more than 15 years.

The approval is based on results of the Phase III VIVID-1 study in adults with moderately to severely active Crohn’s disease with inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics.

Patients were randomly assigned to placebo or Omvoh; those in the placebo group who did not achieve clinical response at 12 weeks were switched to Omvoh treatment.

Both primary end points were achieved; Clinical remission at one year was achieved by 53 and 36 percent of patients treated with Omvoh and placebo, respectively, and visible healing of the intestinal lining at one year occurred in 46 and 23 percent of patients treated with Omvoh and placebo, respectively.

“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, ” Daniel M. Skovronsky, MD, Ph.D., chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, said in a statement.

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