Europe – EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19

EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab / imdevimab). The applicant is Roche Registration GmbH.

Ronapreve, co-developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, is intended for the treatment of COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older.

EMA will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required to support the evaluation…