GlaxoSmithKline Covid treatment approved for use in EU
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GlaxoSmithKline and Vir Biotechnology said on Friday that the European Commission has given marketing authorisation to Xevudy - sotrovimab - for the early treatment of Covid-19.
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Sotrovimab is now approved in the EU for the treatment of adults and adolescents with Covid who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
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).
Dr Hal Barron, chief scientific officer and president of R&D at GSK, said: "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."