FDA Approves Eli Lilly’s Omvoh for Crohn’s Disease Based on Phase III VIVID-1 Trial Outcomes
In the pivotal trial, patients treated with Omvoh experienced significant improvements in clinical remission and endoscopic response at one year.
The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. The therapy is now approved for two types of inflammatory bowel disease (IBD) following its October 2023 approval for moderately to severely active ulcerative colitis (UC) in adults. This most recent approval for Crohn’s disease is based on positive results from the Phase III VIVID-1 clinical trial.1
In a press release, Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation said, "The burden of Crohn's disease on patients' daily lives is substantial. This approval is meaningful for adult patients with Crohn's disease, who now have more treatment options available."
In the VIVID-1 study, 53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo. Additionally, 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo.
"Many patients with Crohn's disease have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease," Marla Dubinsky, MD, chief, division of pediatric gastroenterology and nutrition, co-director, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine, Mount Sinai New York, said in the press release. "The FDA approval of Omvoh may help adults with Crohn's disease achieve long-term remission and visible healing of the intestinal lining, even if they have tried other medications that did not work or stopped working."
Daniel M. Skovronsky, MD, PhD, chief scientific officer, and president of Lilly Research Laboratories and Lilly Immunology added, "People living with Crohn's disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be. 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."
VIVID-1 was a randomized, double-blind, treat-through study that evaluated the safety and efficacy of Omvoh compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. Patients in the Omvoh arm received 900mg of the therapy intravenously every four weeks from week 0-12, then 300mg subcutaneously every four weeks from weeks 12-52.2
Lilly announced the results of the VIVID-1 study earlier in October 2024. In a press release from the time, Fernando Magro, MD, PhD, head of clinical pharmacology at University Hospital São João said, "Treatment strategies for Crohn's disease must evolve beyond traditional measures of clinical remission and endoscopy, to the evaluation of depth of intestinal healing by measuring histologic and transmural resolution. These histologic data build on the growing body of evidence for mirikizumab, which may provide a greater depth of mucosal healing for those living with this chronic, progressive disease."
Omvoh is also being studied in VIVID-2, an ongoing, open-label extension study evaluating the therapy’s effectiveness for up to three years. So far, results have been positive. Among patients who achieved endoscopic response at one year in VIVID-1, over 80% maintained with one year of additional treatment in VIVID-2. Additionally, nearly 90% of this patient population maintained clinical remission.
References
1. FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease. News release. Eli Lilly. January 15, 2025. Accessed January 16, 2025. https://www.prnewswire.com/news-releases/fda-approves-lillys-omvoh-mirikizumab-mrkz-for-crohns-disease-expanding-its-use-to-the-second-major-type-of-inflammatory-bowel-disease-302352349.html
2. Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab compared to ustekinumab for Crohn's disease. News release. Eli Lilly. October 14, 2024. Accessed January 16, 2025. https://www.prnewswire.com/news-releases/lilly-reports-one-year-histologic-outcomes-in-phase-3-study-of-mirikizumab-compared-to-ustekinumab-for-crohns-disease-302274325.html
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