FDA Clears Lilly’s Omvoh for Adults with Moderately to Severely Active Ulcerative Colitis

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Eli Lilly and Company announced in a company press release that the FDA has officially approved Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Currently, the medication is the only interleukin-23p19 (IL-23p19) antagonist indicated for moderately to severely active UC and marks Lilly’s first approved treatment for a type of inflammatory bowel disease.

"Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation," said Patrik Jonsson, EVP, president of Lilly immunology and Lilly USA, chief customer officer. "Omvoh's approval is a significant moment for Lilly's growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with ulcerative colitis."

Reference: FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. Lilly. October 26, 2023. Accessed October 27, 2023. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class