GlaxoSmithKline plc (GSK) and Vir Biotechnology, Inc. (VIR) announced Friday the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136).
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) 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 3 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% reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. VIR-7831 also appears to maintain activity against the California variant.
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.
GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.
The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease.
Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.
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