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Image header Agence Europe
Europe Daily Bulletin No. 12835
Contents Publication in full By article 21 / 31
EU RESPONSE TO COVID-19 / Health

European Medicines Agency could approve GSK's Covid-19 treatment within two months

18/11/2021 (Agence Europe)The European Medicines Agency (EMA) announced on Thursday 18 November that it had started to evaluate an application made for marketing authorisation for the Covid-19 treatment candidate Xevudy (sotrovimab), developed by the British company GSK in collaboration with the American company Vir biotechnology. This monoclonal antibody is intended for the treatment of adults and adolescents who do not require supplemental oxygen therapy, but are at an increased risk of progressing to suffer from severe Covid-19. The EMA launched a rolling review of this treatment last May. The European Commission could therefore make a decision on whether to place it on the European market within two months. The European Commission signed an advance purchase agreement with GSK in July for this treatment (see EUROPE 12771/1): if the EMA evaluation gives a positive recommendation, the EU will be able to receive up to 220,000 doses of Xevudy. (AC)

Contents

SECTORAL POLICIES
ECONOMY - FINANCE - BUSINESS
INSTITUTIONAL
EXTERNAL ACTION
EU RESPONSE TO COVID-19
SOCIAL AFFAIRS - EDUCATION
NEWS BRIEFS