The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Omvoh (mirikizumab-mrkz) for the treatment of 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.
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.
This approval is based on positive results from the Phase 3 VIVID-1 study of Omvoh in adults with moderately to severely active Crohn’s disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) and/or biologics (TNF blockers, integrin receptor antagonists). VIVID-1 was a randomized placebo-controlled trial of Omvoh. 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 year
- 53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo (p<0.001).
- Endoscopic response at one year
- 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo (p<0.001).
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 (p<0.001).
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% of patients maintained clinical remission with one year of additional treatment (two years of continuous treatment).
In both VIVID-1 and VIVID-2, Omvoh’s overall safety profile in patients with moderately to severely active Crohn’s disease was generally consistent with its known safety profile in patients with UC. The most common adverse reactions (reported in at least 5% of subjects and at a higher frequency than placebo during induction and through Week 52 of VIVID-1) associated with Omvoh treatment were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests. The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations.
Lilly has also submitted marketing applications for Omvoh in Crohn’s disease 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.
“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,” said Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer, and president of Lilly Research Laboratories and Lilly Immunology. “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.”
