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The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.
The European Medicines Agency announced on Nov. 11, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing two monoclonal antibody (mAb) drugs to treat COVID-19 patients.
Ronapreve (casirivimab/imdevimab) (Roche Registration GmbH) is being recommended for the treatment of COVID patients who do not require supplemental oxygen but are at risk for severe disease and who are 12 years of age (weighing at least 40 kilograms) and older. It may also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms.
CHMP is recommending authorizing Regkirona (regdanvimab) (Celltrion Healthcare Hungary Kft) for treating adults with COVID-19 at risk for severe disease who do not require supplemental oxygen.
Both mAbs are the first to receive a positive CHMP opinion for treating COVID-19. The committee reached its decision after evaluating data from studies that showed the drugs significantly reduced hospitalization and death in COVID-19 patients. According to EMA, the chance of being infected by a household member with COVID-19 was reduced with Ronapreve.
Both recommendations will be sent to the European Commission for approval.