EMA to review VIR-7831 for the early treatment of COVID-19
The European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody.
Under development at UK pharma major GlaxoSmithKline (LSE: GSK) and partner Vir Biotechnology (Nasdaq: VIR), VIR-7831 is intended for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization Application.
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