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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