FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease
Key Insights
The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease (search) in adults, expanding its use for inflammatory bowel disease.
The approval was based on the VIVID-1 trial, which showed significant clinical remission and endoscopic response rates compared to placebo after one year of treatment.
Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining.
The U.S. Food and Drug Administration (FDA) has granted approval to Eli Lilly's Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease (search) in adults. This decision marks Omvoh as the second therapy approved for inflammatory bowel disease (IBD), following its initial approval for ulcerative colitis (search) in October 2023.
This approval is based on data from the Phase 3 VIVID-1 trial, a randomized, double-blind, placebo-controlled study. The results indicated that 53% of patients treated with Omvoh achieved clinical remission at one year, compared to 36% in the placebo group (p<0.001). Furthermore, 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year, versus 23% on placebo (p<0.001).
VIVID Clinical Trial Program
The VIVID-1 trial involved intravenous administration of mirikizumab 900mg at Week 0, Week 4, and Week 8, followed by a maintenance dose of 300mg via subcutaneous injection at Week 12 and every four weeks thereafter for 40 weeks. Patients on placebo who did not achieve a clinical response by week 12 were switched to Omvoh treatment.
Participants who completed Week 52 of VIVID-1 were eligible for enrollment in VIVID-2, an open-label extension study designed to evaluate the long-term effect of mirikizumab on clinical remission and endoscopic response. Data from VIVID-2, presented at the Crohn's and Colitis Congress, demonstrated that among patients who were in clinical remission at one year in VIVID-1, 92.9% maintained clinical remission at two years, as measured by the Crohn's Disease (search) Activity Index (CDAI).
Long-Term Efficacy and Safety
According to Mark Genovese, M.D., senior vice president of Lilly Immunology development, these results build on the evidence demonstrating Omvoh's ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic, and histologic outcomes.
In terms of safety, the most common adverse reactions associated with Omvoh treatment were upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests. The prescribing information for Omvoh includes warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity, and immunizations.
Addressing Unmet Needs in Crohn's Disease
Crohn's disease (search) is a chronic inflammatory condition affecting the gastrointestinal tract, with a prevalence of 100 to 300 per 100,000 people in western Europe and North America. Symptoms include abdominal pain, frequent bowel movements, and bowel urgency, which can significantly impact patients' daily lives.
"Many patients with Crohn's disease (search) have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease," said Marla Dubinsky, M.D., 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. "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."
Lilly has also submitted marketing applications for Omvoh in Crohn's disease (search) around the globe, including in the European Union and Japan. Additional global regulatory submissions are planned. In UC, Omvoh is currently approved in 44 countries.