FDA Approves Treatment for COVID-19 in Certain Hospitalized Adults
Today, the FDA approved a new indication 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.
The 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. The FDA has revised the Letter of Authorization 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.
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.
Related Information:
Baricitinib EUA Letter of Authorization
Frequently Asked Questions on Olumiant (Baricitinib) for the Treatment of COVID-19
Baricitinib EUA Fact Sheet for Healthcare Providers
Baricitinib EUA Fact Sheet for Patients, Parents, and Caregivers
Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
Coronavirus Treatment Acceleration Program (CTAP)
Coronavirus Disease (COVID-19)
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