EMA Reviews Regeneron/Roche COVID-19 Antibody Cocktail

The European Medicines Agency (EMA) is considering a marketing application by Regeneron and Roche for their monoclonal antibody combination, Ronapreve (casirivimab/imdevimab), for treatment of COVID-19 patients.

The agency is assessing the cocktail for treating adults and adolescents 12 years and older who don’t require supplemental oxygen but who are at increased risk of progressing to severe disease.

The European regulator said it could make a recommendation on the application within two months depending on the strength of the supporting data.  The European Commission, which is the EU’s authorizing body for drugs, issues legally binding decisions based on EMA's recommendations.