GlaxoSmithKline (GSK) and Vir Biotechnology have submitted a request to the US Food and Drug Administration (FDA), seeking an emergency use authorisation (EUA) for their COVID-19 antibody VIR-7831.
The EUA application is seeking authorisation for VIR-7831, an investigational dual-action monoclonal antibody (mAb), for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk of progression to hospitalisation or death.
The submission is based on an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial, which demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831 compared to placebo.
Following this positive result, the independent data monitoring committee recommended that the trial be stopped for enrolment, due to evidence of ‘profound efficacy’.
GSK and Vir Biotech added that data from the COMET-ICE trial will also form the basis of a biologics license application (BLA) submission to the FDA.
The companies are also continuing discussions with the European Medicines Agency (EMA) and other global regulators for the potential approval of VIR-7831 to treat patients with COVID-19.