May 7, 2021 -- GlaxoSmithKline (GSK) and Vir Biotechnology have announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody.
Sotrovimab is being developed for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.
The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine's compliance with the usual standards for efficacy, safety, and quality.
An emergency use authorization application for sotrovimab has been submitted to the U.S. Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada, under the expedited interim order application pathway for COVID-19 drugs.
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