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

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. 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.