The European Medicines Agency(EMA) has begun a “rolling review” of data on an anti-COVID-19 monoclonal antibody treatment developed by Celltrion called CT-P59. 

CT-P59 is South Korea’s first locally developed COVID-19 treatment that secured approval from the South Korean government on February 5. It was provided to medical facilities nationwide starting from last Wednesday.  

The EMA said Wednesday that its human medicines committee has started evaluating the first batch of data from animal studies and clinical trials, in addition to data on the quality of the medicine. 

However, the agency was quick to add that it has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine. 

Celltrion said it submitted such data to the EMA to swiftly acquire global authorization for use of CT-P59. 

A rolling review is a regulatory tool that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.