GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death.

Adrienne E. Shapiro, M.D., Ph.D., an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial, said: “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk – allowing them to avoid hospitalisation or worse.”

George Scangos, Ph.D., Chief Executive Officer of Vir, said: “Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85% reduction in all-cause hospitalisations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India. I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well. At Vir, our aim is not only to deliver a clinically effective therapy for COVID-19, but also to provide effective therapy against SARS-CoV-2 variants and potential pandemics of tomorrow.”

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