European Commission grants EU Marketing Authorisations for SARS-CoV-2 Neutralising Monoclonal Antibodies Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab)
On 12 November 2021, the European Commission granted marketing authorisations for the monoclonal antibodies Ronapreve (casirivimab/imdevimab) from Roche Registration GmbH and Regkirona (regdanvimab) from Celltrion Healthcare Hungary Kft.
The authorisations followed the recommendations of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) on 11 November 2021.
Ronapreve and Regkirona are among the SARS-CoV-2 neutralising antibodies. They are the first monoclonal antibodies for COVID-19 therapy to receive marketing authorisation from the European Commission.