The European regulator announced today that the application for marketing authorisation in the European Union for Ronapreve - a combination of monoclonal antibodies casirivimab and imdevimab - was presented by pharmaceutical company Roche Registration GmbH.
In a statement, the EMA said that the drug, developed in partnership with Regeneron Pharmaceuticals, is intended to prevent Covid-19, as well as to treat adults and adolescents aged 12 years and over who do not need supplemental oxygen and who have increased risk of developing serious illness.
The EMA will assess the benefits and risks of Ronapreve within a “short timeframe” and may issue its opinion within the next two months, depending on the robustness of the data presented by the company and the possible need for more information to support the assessment.
According to the regulator, this evaluation in "such a short period of time is only possible" because the EMA Committee for Human Medicines (CHMP) has already analysed the medicine's data during the continuous review process, a regulatory tool designed to accelerate the evaluation of a new drug in public health emergency situations.
The antibodies casirivimab and imdevimab, designed to be administered intravenously, are designed to bind to the `spike' protein of SARS-CoV-2 at two different sites, preventing the virus from entering the cells of the human body.
This is the second go-to-market application that the EMA is evaluating in the space of a week, after it announced on 4 October an identical process for the antibody Regkirona, intended to treat adults with Covid-19 and presented by Celltrion Healthcare Hungary Kft.