EMA starts review of GSK's monoclonal antibody to treat COVID-19 patients

FILE PHOTO: A GlaxoSmithKline (GSK) logo is seen at the GSK research centre in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls/File Photo

(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. (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.

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