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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.
Is Omvoh™ (mirikizumab-mrkz) approved for the treatment of ulcerative colitis?
On October 26, 2023, the FDA approved Omvoh (mirikizumab) for the treatment of moderately to severely active ulcerative colitis in adults.
Regulatory Decisions
Mirikizumab also received approval for the treatment of ulcerative colitis in Japan, Canada, and the European Union in 2023.1,2
Regulatory decisions in additional markets around the world are expected in the coming months.1
Enclosed Prescribing Information
Reference
1FDA approves Lilly's Omvoh™ (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis. Press release. Eli Lilly and Company; October 26, 2023. Accessed October 27, 2023. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class
2Lilly's Omvoh™ (mirikizumab) now available in Canada - a first-in-class treatment for adults with moderately to severely active ulcerative colitis. Press release. Eli Lilly and Company; October 16, 2023. Accessed November 1, 2023. https://www.lilly.ca/en-CA/news/press-releases/23.10.17-omvoh-colitis-NOC
Date of Last Review: October 27, 2023