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European Commission approves Ronapreve to treat of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation
Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union (EU) and other countries.
The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. This decision follows yesterday’s positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).