EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19
The European Medicines Agency (EMA) has begun a review of GlaxoSmithKline (GSK)’s and Vir Biotechnology’s monoclonal antibody VIR-7831 as a treatment for COVID-19 patients.
The EMA is assessing data from a phase 3 study showing the monoclonal antibody reduced the risk of hospitalization or death in COVID-19 patients by 85 percent vs. placebo.
The agency said it is conducting the review “to support national authorities who may decide on the use of this medicine for COVID-19,” ahead of a more comprehensive review when the companies apply for marketing authorization.
GSK and Vir filed for FDA Emergency Use Authorization for VIR-7831 in late March based on the strong efficacy seen in their phase 3 study.