FDA Approves Olumiant for COVID-19 Treatment


May 12, 2022

On Wednesday, the U.S. Food and Drug Administration (FDA) announced approval of a new indication, or justification for prescription, of the drug Olumiant (baricitinib) for treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Olumiant was initially issued an emergency use authorization (EUA) by the FDA in November of 2020, but only when given in combination with another drug used for COVID-19 treatment, remdesivir. In July of 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. This new approval broadens the scope of individuals who are eligible to receive this drug as a treatment for COVID-19.

The FDA stated in a news release announcing the new approval that "the 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."

Click here to read the relevant FDA news release; click here to access the FDA's revised Letter of Authorization; and click here to access the FDA's revised fact sheet on Olumiant.

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