EMA initiates rolling review of Regeneron’s COVID-19 mAb

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a ‘rolling review’ of data on REGN-COV2 antibody combination (casirivimab/imdevimab) for the treatment and prevention of COVID-19. The treatment is being co-developed by Regeneron Pharmaceuticals and Roche.

The CHMP’s decision to start the rolling review is based on preliminary results from a study that indicate a beneficial effect of the medicine in reducing the amount of coronavirus in the blood in non-hospitalised patients with COVID-19. However, the EMA has not yet evaluated the full study and says it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

REGN-COV2 is made of casirivimab and imdevimab, two monoclonal antibodies (mAbs). A mAb is an antibody that has been designed to recognise and attach to a specific antigen. Casirivimab and imdevimab have been designed to attach to the Spike (S)protein of SARS-CoV-2 at two different sites. When the active substances are attached to the S protein, the virus is unable to enter the body’s cells.

The EMA has now started evaluating the first batch of data on the medicine, which come from laboratory and animal pre-clinical studies. The CHMP will evaluate all data on this medicine, including evidence from a study in hospitalised patients with COVID-19 and other clinical trials as they become available.

The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. Once the CHMP decides that sufficient data are available, the formal application should be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the medicine or vaccine can be authorised. The EMA will assess the medicine’s compliance with the usual standards for effectiveness, safety and quality.