GlaxoSmithKline and Vir Biotechnology today announced the submission of an application to the Food and Drug Administration requesting Emergency Use Authorization 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 emergency use authorization submission is based on an interim analysis of efficacy and safety data from the Phase 3 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.
The United States has already recommended similar therapies from Eli Lilly and Regeneron, while European health regulators are reviewing treatments from the class of medicines called monoclonal antibodies.
These monoclonal antibodies are synthetically manufactured copies of the human body's natural infection-fighting proteins and are already being used to treat some types of cancers. Regeneron's therapy was given to former President Donald Trump during his COVID-19 infection.
GSK and Vir said they are in discussions with the European Medicines Agency and other global regulators for approvals of their treatment, part of a wider collaboration on developing COVID-19 drugs based on monoclonal antibodies.