GSK and Vir seek EUA for monoclonal antibody to treat Covid-19
GlaxoSmithKline (GSK) and Vir Biotechnology have applied for emergency use authorization (EUA) from the US FDA for VIR-7831 (GSK4182136), an investigational dual-action antibody designed to treat Covid-19 in adults and adolescents aged 12 and over weighing at least 40kg with mild to moderate Covid-19 and high risk of progression to
hospitalisation or death.
VIR-7831 is intended to allow optimal penetration into SARS-CoV-2 affected airway tissues through increased concentration in the lungs. The phase III Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE) trial assessed VIR-7831 as a monotherapy for early treatment of Covid-19 in high-risk adults, and interim analysis of efficacy and safety data showed an 85% decrease in hospitalisation or death in patients receiving VIR-7831 versus placebo, the trial’s primary endpoint. The Independent Data Monitoring Committee (DMC) recommended in early
March that trial enrolment be stopped due to evidence of profound efficacy. The registrational data from the trial will also provide the foundation for a biologics license application (BLA) submission to the FDA. Meanwhile, discussions with the European Medicines Agency (EMA) and other global regulators in view of making VIR-7831 available
to Covid-19 patients will continue.
Pre-clinical data suggests that the antibody targets a highly conserved spike protein epitope, making resistance difficult to develop, and could inhibit viral entry into healthy cells and clear infected ones. GSK and Vir have a binding agreement to expand their partnership to research and develop (R&D) novel therapies for influenza and other respiratory viruses.