New FDA Approvals: FDA Grants Additional Indication to Olumiant

May 10: The FDA granted full approval to Eli Lilly and Co.’s Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The agency first approved the Janus kinase (JAK) inhibitor on May 31, 2018. The drug has been available for COVID treatment since Nov. 19, 2020, under Emergency Use Authorization (EUA). The EUA remains in place for hospitalized people between the ages of 2 and 18 years old who require various degrees of oxygen support. The recommended dose of the tablet for the newest use is 4 mg once daily for 14 days or until hospital discharge, whichever occurs first. Alternative modes of administration via oral dispersion, gastrostomy tube, nasogastric tube or orogastric tube are available. The drug’s list price for a 30-day supply of 2 mg tablets is $2,497.20.

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Angela Maas

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.

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