The European Medicines Agency (EMA) has started evaluating an application for marketing authorization for the combination of monoclonal antibodies to ronapre (casirivimab / imdevimab). The applicant is Roche Registration GmbH.
Ronapreve, jointly developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, aims to treat COVID-19 in adults and adolescents 12 years of age and older who do not require additional oxygen therapy and who are at increased risk of developing severe COVID-19, and prevention of COVID-19 in adults and adolescents 12 years of age and older.
The EMA will assess the benefits and risks of ronapre in the short term and may provide an opinion within two months, depending on the appropriateness of the data presented and whether further information is needed to support the assessment.
Such a short timeline is only possible because the EMA Committee for Medicinal Products for Human Use (CHMP) has already evaluated the drug data during an ongoing review. During this phase, the CHMP evaluated data from laboratory and animal studies, as well as data on drug quality. Furthermore, the CHMP evaluated clinical data, including data from a clinical trial investigating the effectiveness of ronapres in preventing hospitalization in adult outpatients with confirmed COVID-19 who did not need additional oxygen. The 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 infection (the virus that causes COVID-19) by a member of the same families diagnosed with COVID-19.
In parallel, the EMA Public Safety Advisory Committee (PRAC) completed its preliminary assessment of the company-proposed Risk Management Plan (RMP), which outlines measures to identify, characterize, and minimize drug risks.
Furthermore, the EMA Committee for Pediatric Drugs (PDCO) issued an opinion on the company’s Pediatric Inquiry (PIP) plans for kazirivimab and imdevimab, which describe how medicines should be developed and studied for use in children accordingly. with accelerated drug timing for COVID-19.
If the additional data submitted with the marketing authorization application is sufficient for the CHMP to conclude that the benefits of ronapres exceed the risks in the context of COVID-19 treatment and prevention, EMA will work closely with the European Commission to expedite the decision. for marketing authorization in all EU and EEA member states.
The EMA will provide further information when the CHMP has given its opinion.
How the medicine is expected to work:
This medicine is made from casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is an antibody (a type of protein) created to recognize and bind to a specific structure (called an antigen). Casirivimab and imdevimab were created to bind to the SARS-CoV-2 spike protein in two different sites. When the active substances bind to the peak protein, the virus cannot enter the cells of the body.
ronapreve is intended to be administered by intravenous injection (drip) or subcutaneous injection.ibna