If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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?
Omvoh (mirikizumab) is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. The prescribing information does not indicate that patients must have failed at least one prior UC medication.
Phase 3 Studies of Mirikizumab in Patients With Ulcerative Colitis
The safety and efficacy of mirikizumab, a p19-directed anti-interleukin-23 (IL-23) antibody, are being evaluated in adult patients with moderately to severely active ulcerative colitis in the phase 3 studies LUCENT-1, LUCENT-2, and LUCENT-3.1-3
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.4
Enclosed Prescribing Information
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1An induction study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-1). ClinicalTrials.gov identifier: NCT03518086. Updated October 27, 2022. Accessed March 27, 2023. https://clinicaltrials.gov/show/NCT03518086
2A maintenance study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-2). ClinicalTrials.gov identifier: NCT03524092. Updated November 25, 2022. Accessed March 27, 2023. https://clinicaltrials.gov/show/NCT03524092
3A study to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-3). ClinicalTrials.gov identifier: NCT03519945. Updated July 13, 2023. Accessed July 26, 2023. https://clinicaltrials.gov/show/NCT03519945
4D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohns Colitis. 2022;16(suppl 1):i028-i029. European Crohn's and Colitis Organisation abstract OP26. https://doi.org/10.1093/ecco-jcc/jjab232.025
Date of Last Review: May 30, 2023