April 16, 2021 -- GlaxoSmithKline (GSK) and Vir Biotechnology announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody (mAb) for the treatment of adults and adolescents 12 years old and over with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The review is being carried out by the EMA's Committee for Human Medicinal Products and will provide European Union-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal marketing authorization application.
The review will include data from an interim analysis of efficacy and safety data from the phase III COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early (COMET-ICE) trial, which evaluated VIR-7831 as a monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary end point of the trial.
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