Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review.

Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment. An application for authorization was filed based on the recently ended global phase II clinical trial.

Based on the clinical results, Celltrion is also starting a procedure for obtaining EUA in the US and Europe.

This global clinical phase II was designed through prior consultation with the MFDS the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). A total of 327 patients from South Korea, Romania,