GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19


13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations

GlaxoSmithKline and Vir Biotechnology today announced the submission of an application to the U.S. FDA requesting an amendment to the emergency use authorisation for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular administration.

Read GSK press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , COVID-19