March 29, 2021 -- GlaxoSmithKline (GSK) and Vir Biotechnology filed an emergency use authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for VIR-7831 (GSK4182136), the firms' investigational dual-action SARS-CoV-2 monoclonal antibody (mAb).
The mAb would be used to treat adolescents (ages 12 and older weighing at least 40 kg) and adults with mild to moderate COVID-19 who are at risk for progression to hospitalization or death.
The EUA submission is based on interim efficacy and safety data from the phase III COVID-19 Monoclonal Antibody Efficacy Trial - Intent to Care Early (COMET-ICE) trial that assessed VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Based on data from 583 patients, interim results show an 85% reduction in hospitalization or death in those receiving VIR-7831 compared with a placebo.
VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop, according to preclinical data. New in vitro data from pseudotyped virus assays published earlier this month support the hypothesis. Additionally, GSK and Vir determined the mAb protects against all known COVID-19 variants.
The firms are continuing discussions with the European Medicines Agency and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible, the firms added.