The Ministry of Food and Drug Safety announced today (29th) that it has begun a license review for Celltrion's Corona 19 antibody treatment,'Recyronaju' (ingredient name Legdanvimab, code name CT-P59).
This is due to today's Celltrion's application to the Ministry of Food and Drug Safety for an item license of Rekirona.
Rekironaju is an antibody treatment made by screening neutralizing antibodies present in the blood of COVID-19 cured people, and as a result of a phase 2 clinical trial, the effect of shortening the recovery period of COVID-19 patients was confirmed.
The Ministry of Food and Drug Safety plans to thoroughly verify the safety and effectiveness of the drug by using the'Corona 19 Vaccine/Treatment Authorization Review Team'.
After that, if safety and effectiveness are sufficiently confirmed, we plan to grant approval on condition that the results of the currently ongoing phase 3 clinical trial are submitted after approval.
The goal is to complete the authorization process within 40 days.
(Photo = Yonhap News)