Visible healing of the intestinal lining was observed in 46% of subjects treated with the therapy. Credit: SewCreamStudio/Shutterstock.

Eli Lilly has received approval from the US Food and Drug Administration (FDA) for Omvoh (mirikizumab-mrkz) to treat moderately to severely active Crohn’s disease in the adult population.

This is the second inflammatory bowel disease indication for the therapy in the US, after its approval for ulcerative colitis (UC) treatment in October 2023.

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The FDA’s decision is supported by the positive outcomes from the Phase III VIVID-1 trial, which assessed the therapy in adults who had an insufficient response or intolerance to standard treatments.

The VIVID-1 trial met both primary endpoints: clinical remission by Crohn’s Disease Activity Index at one year and endoscopic response at the same interval. In the trial, 53% of therapy-treated subjects achieved clinical remission against placebo.

Visible healing of the intestinal lining was observed in 46% of subjects treated with the therapy compared to placebo.

The open-label extension VIVID-2 trial continues to the therapy’s safety and efficacy for up to three years. In both trials, the therapy’s overall safety profile in the Crohn’s disease subjects was consistent with its known safety profile in UC patients.

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By targeting the interleukin-23p19 (IL-23p19) protein, Omvoh aims to decrease inflammation in the gastrointestinal area. It claims to be the first biologic therapy to provide two-year Phase III efficacy data for Crohn’s disease at the approval period.

Lilly Research Laboratories and Lilly Immunology chief scientific officer, and president Daniel Skovronsky stated: “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.”

The company has submitted marketing applications for the therapy in the stated indication to the European Union (EU), Japan and other regulatory bodies worldwide, with additional submissions planned.

In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the therapy for approval in the EU to treat adults with moderately to severely active Crohn’s disease.