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(Adds details of GSK-VIR deal, U.S. application, background on
monoclonal antibodies)
April 15 (Reuters) - The European Medicines Agency said on
Thursday it is reviewing available data on the use of
GlaxoSmithKline's monoclonal antibody to treat COVID-19
patients.
The agency said its review of VIR-7831, which GSK is
developing with Vir Biotechnology Inc, will include data
from a study comparing its effect with that of a placebo in
patients with mild to moderate COVID-19 who were at high risk of
progressing to a more severe condition. (https://bit.ly/3n0spGx)
While a more comprehensive rolling review is expected to
start at a later time, the agency said the current review will
provide European Union-wide recommendations for national
authorities who may take decisions on early use of the medicine.
The companies reported in March that VIR-7831 reduced the
risk of hospitalisation and deaths among patients by 85%, based
on interim data from a study.
In late March, the companies filed an application to U.S.
regulators for emergency use authorization of VIR-7831 to treat
early-stage COVID-19 infections.
The United States has already recommended similar therapies
from Eli Lilly and Co and Regeneron Pharmaceuticals Inc
.
European health regulators are reviewing treatments from
this class of medicines called monoclonal antibodies, which are
synthetically manufactured copies of the human body’s natural
infection-fighting proteins and are already being used to treat
some types of cancers.
GSK and Vir announced a partnership in 2020 to research
COVID-19 treatments, and earlier this year said they will expand
that partnership to develop monoclonal antibody treatments for
influenza and other respiratory illnesses.
(Reporting by Vishwadha Chander in Bengaluru; Editing by
Bernard Orr)
