An EUA for Sotrovimab for Treatment of COVID-19

Date: 
June 28, 2021

Issue #: 

1627

Summary: 
The investigational monoclonal antibody sotrovimab
(VIR-7831; GSK/Vir Biotechnology) has been granted
an FDA Emergency Use Authorization (EUA) for
treatment of mild to moderate COVID-19 in patients
≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death.1 Two other monoclonal
antibody regimens are authorized for the same
indication: casirivimab (REGN10933) and imdevimab
(REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016)
administered together.
The FDA revoked its EUA
for bamlanivimab alone in April 2021 because an
increasing percentage of COVID-19 cases in the US
are being caused by SARS-CoV-2 variants that are
resistant to monotherapy with the drug.