FDA approves COVID-19 treatment for certain hospitalized adults

Last Updated: May 12, 2022

FDA approved a new indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.

FDA first issued an Emergency Use Authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

FDA has revised the Letter of Authorization (PDF) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information (PDF).

FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program. (May 10, 2022)

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