FDA grants emergency use authorization for a COVID-19 antibody drug

The drug is not authorized to be utilized in individuals hospitalized due to the disease.
Food and Drug Administration sign in White Oak, Maryland in July 2020
By Alex Nitzberg

The U.S. Food and Drug Administration has granted an emergency use authorization for the monoclonal antibody sotrovimab to treat mild-to-moderate COVID-19 infections.

The drug is not authorized to be utilized in individuals hospitalized due to the disease, according to the FDA.

"The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19," the FDA noted. "This treatment has not shown benefit in patients hospitalized due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation."