Filenews 12 October 2021
The European Medicines Agency (EMA) has begun to evaluate an application for marketing authorisation for the combination of monoclonal antibodies ronapreve (casirivimab / imdevimab). The applicant is the Roche Registration GmbH.
Ronapreve, jointly developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, is intended to treat 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 progressing to severe cases of COVID-19, as well as for the prevention of COVID-19 in adults and adolescents aged 12 years and older.
The EMA will assess the benefits and risks of ronapreve in a shorter timeframe and may issue an opinion within two months, depending on the adequacy of the submitted data and whether further information is needed to support the evaluation.
Such a short period of time is only possible because the EMA's Committee for Medicinal Products for Human Use (CHMP) has already evaluated the data on the drug 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 drug. 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. The CHMP also evaluated data from a second clinical study examining the drug's effectiveness in preventing COVID-19 in adults and children at risk of SARS-CoV-2 infection (the virus that causes COVID-19) from a member of the same household diagnosed with COVID-19.
At the same time, the EMA's Safety Committee (PRAC) completed the preliminary evaluation of the risk management plan (RMP) proposed by the company, which outlines measures to identify, characterize and minimise the risks of the drug.
In addition, the EMA Committee on Medicines in Children (PDCO) issued an opinion on the company's paediatric investigation plans (PIP) for casirivimab and imdevimab, which describe how medicines should be developed and studied for use in children, in line with accelerated timelines for drugs for COVID-19.
If the additional data submitted with the application for marketing authorisation are sufficient for the CHMP to conclude that the benefits of ronapreve outweigh the risks in the treatment and prevention of COVID-19, the EMA will work closely with the European Commission to accelerate the decision to grant marketing authorisation in all EU and EEA Member States.
The EMA will provide further information when the CHMP is consulted.
How is the drug expected to act:
This drug is made from casirivimab and imdevimab, two monoclonal antibodies. Monoclonal antibody is the antibody (a type of protein) that is designed to recognize and attach to a specific structure (called antigen). Casirivimab and imdevimab are designed to adhere to the SARS-CoV-2 spike protein in two different locations. When the active substances bind to the spike protein, the virus can not enter the cells of the body.
Ronapreve is intended to be administered by intravenous infusion (drip) or subcutaneous injection.
