FDA authorized another monoclonal antibody, sotrovimab, for emergency use in COVID-19 patients at high risk of severe disease, the agency announced on Wednesday.
Sotrovimab received emergency use authorization (EUA) for patients 12 years and older with mild to moderate COVID-19, who tested positive for SARS-CoV-2 and are at risk of progression to hospitalization or death. It is not authorized for hospitalized patients, especially patients requiring supplemental oxygen or mechanical ventilation, as it may worsen clinical outcomes in this population, the FDA said.
