EMA gives positive nod to GSK, Vir COVID-19 mAb

By The Science Advisory Board staff writers

May 21, 2021 -- GlaxoSmithKline (GSK) and Vir Biotechnology today announced that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab, a monoclonal antibody (mAb), to the CHMP.

The opinion relates to the use of the investigational monoclonal antibody for the treatment of adults and adolescents ages 12 years and over and weighing at least 40 kg with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

The CHMP opinion can now be considered by the national authorities in European Union member states when making decisions on the early use of the medicine prior to marketing authorization.

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Last Updated ls 5/24/2021 8:17:21 AM