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Xevudy approved in Europe to treat COVID-19
Xevudy approved in Europe to treat COVID-19.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 0732W\n GlaxoSmithKline PLC\n 17 December 2021\n \n \n \n \n Issued: 17 December 2021, London UK and San Francisco, US\n \n \n \n \n \n \n Xevudy\n \n \n (sotrovimab) granted marketing authorisation by the European Commission for the early treatment of COVID-19\n \n \n \n \n \n \n \n \n \n \n \n \n GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorisation to Xevudy (sotrovimab) for the early treatment of COVID-19. Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.\n \n \n \n \n \n The grant of the marketing authorisation in the EU is a result of the positive opinion issued on 16 December by the European Medicines Agency's Committee for Human Medicinal Products (CHMP). \n \n \n \n \n \n In July 2021, GSK and Vir announced a Joint Procurement Agreement (JPA) with the EC to supply up to 220,000 doses of sotrovimab. Following the grant of the marketing authorisation in the EU, Member States participating in the JPA can now order sotrovimab to support their pandemic responses.\n \n \n \n \n \n \n Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: \n \n \"Since the start of the pandemic we have seen an unprecedented effort by governments, academia and industry to find solutions to help as many people as quickly as possible. COVID-19 therapeutics are an important part of the solution. We have already been working to lay the foundation for more patients across Europe to access sotrovimab through the Joint Procurement Agreement with the European Commission. With today's marketing authorisation we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients.\"\n \n \n \n \n \n \n George Scangos, PhD, chief executive officer of Vir\n \n \n , said\n \n \n : \n \n \"The grant of the marketing authorisation in the European Union for \n sotrovimab \n marks yet another important milestone in our efforts to combat COVID-19, as it allows us to expand access across multip...