FDA Approves Expanded Use Of Eli Lilly's Ulcerative Colitis Drug For Crohn's Disease

On Wednesday, the FDA approved Eli Lilly And Co’s LLY Omvoh (mirikizumab-mrkz) for moderately to severely active Crohn’s disease in adults.

Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.

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Omvoh 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.

Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn’s disease at the time of approval.

The approval is based on results from the Phase 3 VIVID-1 study. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks (40% of placebo patients) were subsequently switched to Omvoh treatment. Both primary endpoints in VIVID-1 were achieved:

• Clinical remission by Crohn’s Disease Activity Index (CDAI) at one year53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo.
• Endoscopic response at one year46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo.

Additionally, 32% of Omvoh patients achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, versus 11% on placebo at three months.

Omvoh is also being studied in VIVID-2, an ongoing, open-label extension (OLE) study evaluating the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn’s disease.

Among patients who achieved endoscopic response at one year in VIVID-1, over 80% maintained endoscopic response with one year of additional treatment (two years of continuous treatment).

Additionally, among patients who achieved clinical remission and endoscopic response at one year in VIVID-1, nearly 90% maintained clinical remission with one year of additional treatment (two years of continuous treatment).

Price Action: LLY stock is down 0.29% at $755.40 during the premarket session at last check Friday.

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