European Medicines Agency Begins Review of Celltrion's COVID-19 Antibody Treatment

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The European Medicines Agency (EMA) has initiated a rolling review of Celltrion's COVID-19 antibody treatment 'Rekkiro-na-ju' (generic name Regdanvimab·CT-P59).

On the 24th (local time), EMA announced this in a press release. A rolling review is a procedure designed to expedite the evaluation of promising medicines or vaccines during public health emergencies such as pandemics.

Normally, all supporting data must be submitted when starting the evaluation process. However, a rolling review examines data from ongoing studies before a formal marketing authorization application is submitted.

EMA decided to start the rolling review based on preliminary study results of Rekkiro-na-ju. EMA stated, "We will evaluate all data on Rekkiro-na-ju as soon as it becomes available," adding, "We will assess whether its efficacy, safety, and quality meet the usual standards."

The EMA's review schedule for Rekkiro-na-ju is expected to proceed faster than usual. EMA said, "The overall review timeline is not yet predictable, but it will be faster than usual."

Rekkiro-na-ju, Korea's first domestically developed COVID-19 treatment, received conditional approval from the Ministry of Food and Drug Safety on the 5th. It has been supplied to medical institutions nationwide since the 17th.

This content was produced with the assistance of AI translation services.