The European Medicines Agency (EMA) began Monday to evaluate whether the COVID-19 drug Ronapreve can be marketed in the European Union, the EU’s main drug regulator announced.
The medicine, co-developed by US-based Regeneron Pharmaceuticals and the Swiss pharma company Roche, is meant to treat and prevent COVID-19 in people over 12 years of age.
“The EMA will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months,” it said, explaining that they have already done a pre-assessment called a rolling review based on data from laboratory and animal studies as well as clinical trials.
The drug is made of a combination of two monoclonal antibodies, casirivimab and imdevimab, which were designed to recognize and attach to the spike protein of the COVID-19 virus.
Patients can receive Ronapreve by infusion into a vein or by injection under the skin.