GSK, Vir Say EMA Starts Review of VIR-7831 for Covid-19
April 15 2021 - 10:57AM
Dow Jones News
By Michael Dabaie
GlaxoSmithKline PLC and Vir Biotechnology Inc. said the European
Medicines Agency has started a review of VIR-7831 for the early
treatment of Covid-19.
The companies said the review is for VIR-7831 for adults and
adolescents 12 years and over with Covid-19 who don't require
oxygen supplementation and who are at high risk of progressing to
severe Covid-19.
GlaxoSmithKline ADRs were up 5% to $38.04 ion morning trading
and Vir shares were up 0.3% to $45.69.
The review is being carried out by the EMA's Committee for Human
Medicinal Products.
The review will include data from an interim analysis of
efficacy and safety data from the Phase 3 COMET-ICE trial. GSK is
planning to submit a full marketing authorization application to
the EMA which will include the data from the COMET-ICE trial.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
April 15, 2021 10:42 ET (14:42 GMT)
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