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GSK to seek regulatory approval for Covid-19 antibody following positive clinical trial study
StockMarketWire.com
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Drug companies GlaxoSmithKline GSK and Vir Biotechnology said they would seek authorization in the US and other countries for their Covid-19 antibody after late-stage clinical trials showed the drug reduced hospitalisation and risk of death by 85% and was effective against other variants.
The phase 3 COMET-ICE data demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial.
Additional new in vitro studies also indicated VIR-7831 maintained activity against major circulating COVID-19 variants including the UK, South Africa and Brazilian variants.
'Based on these results, Vir and GSK plan to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration and for authorisations in other countries,' the company said.
Data from this registrational trial would also form the basis for a Biologics License Application (BLA) submission to the FDA.
Story provided by StockMarketWire.com
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