EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19.
The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to treat COVID-19. However, EMA has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.
EMA has started evaluating the first batch of data, which come from animal studies (non-clinical data) and clinical trials, in addition to data on the quality of the medicine.
The EMA will evaluate all data on this medicine as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.
EMA will assess the medicine’s compliance with the usual standards for effectiveness, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.
How is the medicine expected to work?
Regdanvimab is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalisation in patients with mild to moderate COVID-19.