GSK, Vir Seek FDA Emergency Use Authorization for VIR-7831 in Covid-19
March 26 2021 - 9:20AM
Dow Jones News
By Michael Dabaie
GlaxoSmithKline PLC and Vir Biotechnology Inc. said they
submitted an application to the U.S. Food and Drug Administration
requesting emergency use authorization for VIR-7831 for the early
treatment of Covid-19.
The submission is for VIR-7831, an investigational SARS-CoV-2
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 FDA EUA submission is based on an interim analysis of
efficacy and safety data from a Phase 3 trial, which evaluated
VIR-7831 as monotherapy for the early treatment of Covid-19 in
adults at high risk of hospitalization, the company's said.
Results of the interim analysis, based on data from 583 patients
enrolled in the trial, demonstrated an 85% reduction in
hospitalization or death in those receiving VIR-7831 compared to
placebo, the primary endpoint of the trial. As a result, the
Independent Data Monitoring Committee recommended that the trial be
stopped for enrollment due to evidence of profound efficacy.
Vir shares were up 1.5% to $53.48 in premarket trading.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 26, 2021 09:05 ET (13:05 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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