Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19

LONDON and SAN FRANCISCO, Dec. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorization 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.

The grant of the marketing authorization in the EU is a result of the positive opinion issued on December 16 by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

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 authorization in the EU, Member States participating in the JPA can now order sotrovimab to support their pandemic responses.

Dr Hal Barron, Chief Scientific Officer and President R&D, 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 authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients.”

George Scangos, Ph.D., Chief Executive Officer of Vir, said: “The grant of the marketing authorization in the European Union for sotrovimab marks yet another important milestone in our efforts to combat COVID-19, as it allows us to expand access across multiple countries working to address this challenge. Given recent preclinical data from our own labs, as well as that of other independent labs, demonstrating that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest, we remain confident in the critical role of sotrovimab and look forward to further contributing to the fight against this pandemic.”

The grant of the marketing authorization in the EU is based on data from the COMET-ICE Phase 3 trial, demonstrating that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) (p