GSK and Vir file EUA request for VIR-7831 for early treatment of COVID-19

UK pharma major GlaxoSmithKline (LSE: GSK) and Vir Biotechnology (Nasdaq: VIR) have submitted an application to the US Food and Drug Administration requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

The FDA EUA submission is based on 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 patients enrolled in the trial, 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. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.