Eli Lilly's Recently Approved Inflammatory Bowel Disease Drug Shows Sustained And Durable Treatment At Two Years

Zinger Key Points

92.9% of patients in clinical remission at one year maintained remission at two years, and 87.6% sustained an endoscopic response.
Among those not in clinical remission at one year, 60.8% achieved remission in the second year, while 35.4% gained endoscopic remission.

On Friday, Eli Lilly And Cao LLY announced the results from the VIVID-2 open-label extension study of Omvoh (mirikizumab-mrkz).

In January, the FDA approved Omvoh 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.

The trial showed that most patients with moderately to severely active Crohn's disease received two years of continuous treatment with Omvoh and achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure.

Among patients in clinical remission at one year in VIVID-1, 92.9% maintained clinical remission at two years.
Among patients treated in VIVID-2, 87.6% maintained endoscopic response, defined by visible healing of the intestinal lining.
Among patients in endoscopic remission at one year of treatment in VIVID-1, 78.6% maintained endoscopic remission at two years.

Additionally:

Among patients not in clinical remission at one year, 60.8% gained clinical remission during the second year of treatment.
Among patients not in endoscopic remission at one year, 35.4% gained endoscopic remission during the second year of treatment.

In VIVID-2, Omvoh's long-term safety profile in patients with moderately to severely active Crohn's disease was generally consistent with its known safety profile.

In October, Eli Lilly announced data from a VIVID-1 Phase 3 study that evaluated the safety and efficacy of mirikizumab compared with a placebo and active control (Johnson & Johnson's JNJ Stelara (ustekinumab)) in adults with moderately to severely active Crohn's disease.

The data showed that more patients who achieved histologic response were observed with mirikizumab at Week 52 in the overall population (58.2% versus 48.8%; p=0.0075).

Data from two Phase 3 studies of mirikizumab across two types of inflammatory bowel diseases showed patients treated with mirikizumab sustained stable, long-term remission in ulcerative colitis and Crohn's disease.

Price Action: LLY stock is up 0.20% at $872.14 during the premarket session on last check Friday.

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