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GSK, Vir’s COVID-19 mAb scores FDA emergency use approval
Interim phase 3 trial results found sotrovimab reduced the risk of hospitalisation or death by 85% compared to placebo
GlaxoSmithKline (GSK) and Vir Biotech’s COVID-19 monoclonal antibody (mAb) sotrovimab has been granted an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).
The EUA clears sotrovimab – previously known as VIR-7831 – for the treatment of mild-to-moderate COVID-19 in high-risk adults and certain paediatric patients who have a positive SARS-CoV-2 test.
Interim trial results from a phase 3 trial evaluating the mAb found that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo.
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