FDA Approves Mirikizumab for Crohn Disease

The FDA granted mirikizumab-mrkz (Omvoh; Eli Lilly) an expanded indication for Crohn disease, meaning the drug can now be used to treat the full spectrum of patients with inflammatory bowel disease (IBD).¹

Although the 2 IBD subtypes are similar, inflammation indicative of Crohn disease occurs in the digestive tract, while ulcerative colitis is limited to the colon and rectum. | Image credit: sdecoret - stock.adobe.com

IBD is an umbrella term for ulcerative colitis and Crohn disease. Mirikizumab was originally approved to treat moderate to severe ulcerative colitis in October 2023, and it works to reduce inflammation within the gastrointestinal tract by targeting interleukin-23p19, a key contributor to intestinal inflammation. The approval also marks the first time in over 15 years that a pharmaceutical company disclosed 2-year phase 3 efficacy data for Crohn disease at the time of its approval.

A 2023 study, published in Gastroenterology, estimated that 2.39 million Americans have IBD, 1.25 million of whom are diagnosed with ulcerative colitis and 1.01 million who have Crohn disease.² The incidence peaks in early adulthood and then levels off at a lower rate. The disease is less frequently diagnosed among Black, Asian, and Hispanic Americans, who have been found to face greater barriers to specialist access, worse clinical outcomes, lower quality of life, more medication concerns, and increased emergency department use compared with White/non-Hispanic patients.^2,3

Although the 2 IBD subtypes are similar, inflammation indicative of Crohn disease occurs in the digestive tract, while ulcerative colitis is limited to the colon and rectum.⁴

"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," said Marla Dubinsky, MD, chief, division of pediatric gastroenterology and nutrition, and 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."

Michael Osso, president and CEO, Crohn's & Colitis Foundation, commented in a statement, "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."

Omvoh is provided as a single-dose vial for intravenous infusion (300 mg/15 mL) and is administered in a health care facility.

The approval was based on the VIVID-1 trial, a 52-week, randomized, double-blind, placebo-controlled study where patients received 900 mg of mirikizumab via intravenous infusion at weeks 0, 4, and 8. These infusions were followed by maintenance doses of 300 mg via subcutaneous injection every 4 weeks starting at week 12. Clinical remission (Clinical Disease Activity Index score < 150) and endoscopic response (> 50% reduction in Simple Endoscopic Score for Crohn Disease score) were key end points, along with an assessment of bowel urgency using a numeric rating scale.

Patients receiving placebo who did not have a clinical response at week 12 (40%) were switched to mirikizumab. Patients completing VIVID-1 and deemed to benefit clinically entered the VIVID-2 extension study, evaluating remission and endoscopic response over 104 weeks of continuous treatment. Although the open-label design of VIVID-2 analysis allowed for long-term safety assessment, it may have introduced selection bias, as non-responders or those intolerant to treatment discontinued treatment.

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. Press release. Eli Lilly and Company. January 15, 2024. Accessed January 24, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease

2. Lewis JD, Parlett LE, Funk MLJ, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165(5):1197-1205. doi:10.1053/j.gastro.2023.07.003

3. Shah S, Shillington AC, Kabagambe EK, et al. Racial and ethnic disparities in patients with inflammatory bowel disease: an online survey. Inflamm Bowel Dis. 2024;30(9):1467-1474. doi:10.1093/ibd/izad194

4. Crohn’s & ulcerative colitis: know the diference? WebMD. Updated April 12, 2023. Accessed January 24, 2025. https://www.webmd.com/ibd-crohns-disease/crohns-colitis-difference