|Real-time Estimate - 06/24 04:45:13 pm|
GSK, Vir Say EMA Starts Review of VIR-7831 for Covid-19
|04/15/2021 | 08:42am|
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 firstname.lastname@example.org
(END) Dow Jones Newswires