EMA Commences Rolling Review of Regdanvimab

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

EMA revealed in a Feb. 24, 2021 press release, that the decision to start the rolling review of regdanvimab has been based on preliminary results from an ongoing study assessing the therapy’s ability to treat COVID-19. However, the full data set has not yet been evaluated and the regulatory agency stressed that it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

The first batch of data, which has been obtained via animal studies and clinical trials, are currently being evaluated by EMA along with any data relating to the quality of the medicine. All data will be evaluated by EMA as they become available, with the rolling review continuing until sufficient evidence is available to support a formal marketing authorization application.