Europe Evaluates Regeneron - Roche COVID-19 Monoclonal Antibody Combination
The European Medicines Agency (EMA) announced today it has started evaluating Roche Registration GmbH's application for marketing authorization for the monoclonal antibody combination Ronapreve (REGEN-CoV; casirivimab / imdevimab).
Ronapreve, co-developed by Regeneron Pharmaceuticals Inc. and Roche, is intended to treat COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19 and preventing COVID-19 in adults and adolescents aged 12 years and older.
A monoclonal antibody is an antibody (protein) that has been designed to recognize and attach to a specific structure (antigen).
Ronapreve has been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are connected to the spike protein, the virus is unable to enter the body's cells.
Ronapreve is intended to be given by infusion (drip) into a vein or injection under the skin.
EMA will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required to support the evaluation.
This short timeframe is only possible because EMA's human medicines committee (CHMP) has already reviewed data on the medicine during a rolling review.
Furthermore, EMA's Committee for medicines for children issued its opinion on the company's pediatric investigation plans, which describe how Ronapreve should be developed and studied for use in children, in accordance with the accelerated timelines for COVID-19 medicines.
Previously, Japan's Ministry of Health, Labour, and Welfare approved Ronapreve on July 20, 2021, to treat patients with mild to moderate COVID-19 via intravenous infusion.
Furthermore, the U.S. FDA updated its Emergency Use Authorization for REGEN-COV on July 30, 2021, to includes post-exposure prevention in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual.
The European Medicines Agency is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines. An independent Management Board governs the EMA.