GlaxoSmithKline, Vir Biotechnology Submit Emergency Authorization for Covid-19 Treatment to FDA
March 26 2021 - 8:59AM
Dow Jones News
By Cecilia Butini
GlaxoSmithKline PLC said Friday that it has submitted an
application for emergency authorization at the U.S. Food and Drug
Administration for a Covid-19 treatment together with Vir
Biotechnology Inc.
The company said the drug, named VIR-7831, is an
investigational, dual-action monoclonal antibody for the treatment
of adults and adolescents with mild-to-moderate Covid-19 who are at
risk for progression to hospitalization or death.
The submission is based on data from a Phase 3 clinical trial
named COMET-ICE.
GlaxoSmithKline and Vir will continue discussions with the
European Medicines Agency and other regulators around the world to
make the drug available, Glaxo said.
Write to Cecilia Butini at cecilia.butini@wsj.com
(END) Dow Jones Newswires
March 26, 2021 08:44 ET (12:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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