The European Medicines Agency (EMA) has started evaluating a marketing authorisation application for the monoclonal antibody combination ronapreve (casirivimab/imdevimab). The applicant is Roche Registration GmbH.
Ronapreve, jointly developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, is intended for the treatment of COVID-19 in adults and adolescents aged 12 years and older who do not require supplemental oxygen therapy and who are at increased risk of developing severe COVID-19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older.
The EMA will evaluate the benefits and risks of ronapreve in a shorter timeframe and may issue an opinion within two months, depending on the adequacy of the data submitted and whether further information is needed to support the evaluation.
Such a short timeframe is only possible because the EMA’s Committee for Medicinal Products for Human Use (CHMP) has already assessed the data for the medicine during a rolling review. During this phase, the CHMP evaluated data from laboratory and animal studies, as well as data on the quality of the medicine. In addition, the CHMP evaluated clinical data, including data from a clinical trial that investigated the effectiveness of ronapreve in preventing hospitalization in adult outpatients with confirmed COVID-19 who did not need supplemental oxygen. CHMP also evaluated data from a second clinical trial examining the effectiveness of the drug in preventing COVID-19 in adults and children at risk of SARS-CoV-2 (the virus that causes COVID-19) infection from a member of the same household diagnosed with COVID-19.
In parallel, the EMA’s Public Safety Advisory Committee (PRAC) completed its preliminary assessment of the company’s proposed Risk Management Plan (RMP), which outlines measures to identify, characterise and minimise the risks of the medicine.
In addition, the EMA’s Paediatric Drugs Committee (PDCO) issued an opinion on the company’s paediatric investigation plans (PIPs) for casirivimab and imdevimab, which describe how the drugs should be developed and studied for use in children in accordance with the accelerated timelines for drugs for COVID-19.
If the additional data submitted with the marketing authorisation application is sufficient for the CHMP to conclude that the benefits of ronapreve outweigh the risks in the context of the treatment and prevention of COVID-19, the EMA will work closely with the European Commission to expedite the marketing authorisation decision in all EU and EEA Member States.
The EMA will provide further information when the CHMP has issued its opinion.
How the medicine is expected to act:
This medicine is made from casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is an antibody (a type of protein) designed to recognise and bind to a specific structure (called an antigen). Casirivimab and imdevimab are designed to bind to the SARS-CoV-2 spike protein at two different sites. When the active substances bind to the spike protein, the virus cannot enter the body’s cells.
ronapreve is intended to be administered by intravenous injection (drip) or subcutaneous injection./ibna