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Omvoh ® (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Omvoh® (mirikizumab-mrkz) be used for the first-line treatment of ulcerative colitis?
Mirikizumab is indicated for the treatment of moderately to severely active ulcerative colitis in adults. The prescribing information does not indicate that patients must have failed at least one prior medication for ulcerative colitis.
Indication for Ulcerative Colitis
Mirikizumab is indicated for the treatment of moderately to severely active ulcerative colitis in adults.1
Phase 3 Studies of Mirikizumab in Patients With Ulcerative Colitis
The safety and efficacy of mirikizumab, a p19-directed anti-interleukin-23 antibody, was evaluated in adult patients with moderately to severely active ulcerative colitis in the phase 3 studies LUCENT-1, LUCENT-2, and LUCENT-3.2,3
To participate in the phase 3 clinical studies of mirikizumab for the treatment of moderately to severely active ulcerative colitis, patients must have had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.2
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2D'Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. https://doi.org/10.1056/NEJMoa2207940
3Sands BE, D'Haens G, Clemow DB, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. Published online October 25, 2024. https://doi.org/10.1093/ibd/izae253
Date of Last Review: February 24, 2025