GSK + Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR 7831 for the early treatment of COVID-19.

GlaxoSmithKline 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, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) 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 (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-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 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR 7831 as 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% (p=0.002) reduction in hospitalization or death in those receiving VIR 7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. The CHMP review will also consider data on the medicine’s quality and safety. The Australian Therapeutic Goods Administration (TGA), part of the Department of Health, granted VIR 7831 a provisional determination. VIR 7831 is the first anti-SARS-CoV-2 monoclonal antibody to have been granted this designation which provides a formal and transparent mechanism for accelerating the registration of promising new medicines with preliminary clinical data.