Europe Begins Rolling-Review of Antibody Combination Treatment

The European Medicines Agency (EMA) announced the Human Medicines Committee (CHMP) had started a ‘rolling review’ of data of the medicine known as REGN-COV2 antibody combination (casirivimab / imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID-19.

The CHMP’s decision to start the rolling review of REGN-COV2 on February 1, 2021, is based on preliminary results from a study that indicates a beneficial effect of the medicine in reducing the amount of virus in the blood (viral load) in non-hospitalized patients COVID-19. However, EMA has not yet evaluated the full study, and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

According to the EMA, this medicine is made of casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognize and attach to a specific structure (called an antigen). Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are attached to the spike protein, the coronavirus cannot enter the body’s cells.