New FDA Approvals: Lilly’s Omvoh Approved for Crohn’s

Feb 13
Feb 13, 2025

Jan. 15: The FDA approved Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz) for the treatment of adults with moderately to severely active Crohn’s disease. The agency first approved the interleukin-23p19 (IL-23p19) inhibitor on Oct. 26, 2023. Dosing for the newest indication starts with 900 mg via a 90-minute-plus intravenous infusion at weeks zero, four and eight; maintenance dosing is 300 mg via subcutaneous injection at week 12 and then every four weeks. The agent’s list price is $9,593.22 for one 300mg/15ml infusion and $10,878.70 for two 100mg injections.

Jan. 15: The FDA approved two new vial sizes of Incyte Corp. and Syndax Pharmaceuticals’ Niktimvo (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) after the failure of at least two lines of systemic therapy in adults and pediatric patients weighing at least 40 kg. The agency first approved the colony stimulating factor-1 receptor (CSF-1R)-blocking antibody on Aug. 14, 2024, as a 50 mg single-dose vial, and it now also has 9 mg and 22 mg vials. The recommended dose is 0.3 mg/kg via a 30-minute intravenous infusion every two weeks. At the time of the initial approval, the company said that it was waiting to launch until those smaller vial sizes were approved. All three sizes are now available. The price of a 9 mg vial is $4,725, and the price of the 22 mg vial is $11,550.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.