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Image header Agence Europe
Europe Daily Bulletin No. 12805
EU RESPONSE TO COVID-19 / Health

EMA could give opinion on approval of Covid-19 treatment candidate Regkironawithin two months

05/10/2021 (Agence Europe)On Monday 4 October, the European Medicines Agency began the evaluation of a market authorisation application for the monoclonal antibody Regkirona (CT-P59), which could be used to treat adults with Covid-19 who do not require additional oxygen therapy but are at increased risk of progression to severe Covid-19. The application was submitted by Celltrion Healthcare Hungary Kft and, according to the EMA, could be answered within two months, “depending on the robustness of the data submitted”. Such a short time frame is possible because a rolling review of the drug has already been carried out. Regkirona is the fourth Covid-19 treatment candidate to be submitted for marketing authorisation. Three other treatments are still under evaluation, but have not yet been approved. More details: https://bit.ly/3uOMP9i (AC)

Contents

EXTERNAL ACTION
ECONOMY - FINANCE - BUSINESS
EU RESPONSE TO COVID-19
SECTORAL POLICIES
EUROPEAN PARLIAMENT PLENARY
FUNDAMENTAL RIGHTS - SOCIETAL ISSUES
COUNCIL OF EUROPE
NEWS BRIEFS