FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

The US Food and Drug Administration has approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active Crohn's disease (CD).1

Announced on January 15, 2025, the decision marks mirikizumab's second approval in inflammatory bowel disease (IBD) since 2023, when it was approved as a first-in-class treatment for moderately to severely active ulcerative colitis (UC).2 According to a release from Lilly, mirikizumab is the first biologic treatment in more than 15 years to have disclosed 2-year phase 3 efficacy data in CD at the time of approval.1

"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 of the division of pediatric gastroenterology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine, said in a 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."

The interleukin-23p19 antagonist’s approval is based on positive results from the phase 3 VIVID-1 study in adults with moderately to severely active CD who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics.

In the randomized, double-blind, placebo-controlled 52-week study, patients received mirikizumab 900 mg by intravenous infusion at weeks 0, 4, and 8 followed by a maintenance dose of 300 mg by subcutaneous injection at week 12 and then every 4 weeks for 40 weeks. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks were subsequently switched to mirikizumab treatment.

Both primary endpoints in VIVID-1 were achieved, with 53% of patients treated with mirikizumab achieving clinical remission at 1 year versus 36% on placebo (P <.001) and 46% of patients treated with mirikizumab experiencing visible healing of the intestinal lining at 1 year versus 23% on placebo (P <.001). Additionally, 32% of mirikizumab patients achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, versus 11% on placebo at three months (P <.001).

Mirikizumab is also being studied in VIVID-2, an ongoing, open-label extension study evaluating its efficacy and safety for up to 3 years in adults with moderately to severely active CD. Among patients who achieved endoscopic response at 1 year in VIVID-1, more than 80% maintained endoscopic response with 1 year of additional treatment. Among patients who achieved clinical remission and endoscopic response at 1 year in VIVID-1, nearly 90% of patients maintained clinical remission with 1 year of additional treatment.

The most common adverse reactions associated with mirikizumab were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests. Of note, the labeling for mirikizumab contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity, and immunizations.

"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, MD, PhD, 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."

References

1. Lilly. FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease. January 15, 2025. Accessed January 15, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease
2. Campbell P. FDA Approves Mirikizumab (Omvoh) for Ulcerative Colitis. HCPLive. October 26, 2023. Accessed January 15, 2025. https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-ulcerative-colitis