FDA issues EUA for GSK-Vir COVID-19 mAb treatment

By The Science Advisory Board staff writers

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody (mAb) therapy sotrovimab from GlaxoSmithKline (GSK) and Vir Biotechnology. Sotrovimab is a treatment for mild to moderate COVID-19 in adults and pediatric patients over 12 years of age.

The patients must have positive results of direct SARS-CoV-2 viral testing and must be at high risk for progression to severe COVID-19, the agency said. The FDA will continue to evaluate the investigational treatment.

GSK submitted data from a phase I/II/III randomized, double-blind, placebo-controlled clinical trial in 583 nonhospitalized adults with mild to moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. In these studies, 291 patients received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. Hospitalization or death occurred in 7% patients who received a placebo compared to 1% patients treated with sotrovimab, an 85% reduction.

Sotrovimab, developed by GSK and Vir Biotechnology, is an mAb that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block attachment of the virus and its entry into human cells. The FDA specified that sotrovimab be distributed and administered intravenously as a 500-mg single dose.


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