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GlaxoSmithKline, Vir Biotechnology secure FDA emergency use authorization for Covid-19 antibody
StockMarketWire.com
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GlaxoSmithKline and Vir Biotechnology said US Food and Drug Administration granted an emergency use authorization for sotrovimab an investigational monoclonal antibody to treat mild-to-moderate COVID-19 in adults and paediatric patients.
The approval was based on based on interim Phase 3 COMET-ICE trial results showing treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalisation or death in high-risk adult outpatients compared to placebo.
In vitro data indicated sotrovimab maintained 'activity against all known variants of concern, including the variant from India,' GSK said.
'Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the US in the coming weeks,' it added.
GSK and Vir planned to submit a biologics license application for Sotrovimab to the FDA in the second half of 2021.
Story provided by StockMarketWire.com
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