GlaxoSmithKline and Vir win FDA emergency authorization for COVID antibody treatment in adults and children

GlaxoSmithKline plc and Vir Biotechnology Inc. said the U.S. Food and Drug Administration has granted emergency use authorization to its single-dose monoclonal antibody treatment sotrovimab in mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk of severe illness, including hospitalization or death. Vir Chief Executive George Scangos said an interim analysis of data produced in a laboratory found the antibody treatment showed an 85% reduction in all-cause hospitalizations or death and is effective against all known variants of concern, including the emerging variant from India. The companies are still conducting clinical trials of the treatment and expects to provide analysis of safety and efficacy data at day 29 as early as the first half of 2021 and plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.

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