The Ministry of Food and Drug Safety announced on the 5th whether to approve Celltrion corona treatment

Input 2021.02.01 15:10 | Revision 2021.02.01 16:08

Celltrion (068270)On the 5th, it will be decided on the 5th whether or not to permit the use of the antibody treatment drug’Rekironaju’ for a novel coronavirus infection (Corona 19) in Korea. The Ministry of Food and Drug Safety announced on the 1st, “The final decision is made on whether or not to approve the state through the final inspection committee on the 5th and the results will be disclosed on the same day.”

The final inspection committee is the last step of the three-fold consultation of experts for the approval of the Ministry of Food and Drug Safety in Rekirona. The Safety and Effectiveness Verification Advisory Group and the Central Pharmacist Review Committee (Central Pharmacist), which had previously advised twice, recommended that Rekkirona could be given priority on the condition of proceeding and completing phase 3 clinical trials.

However, the Central Pharmacopoeia recommended administering to moderately ill patients and high-risk patients with mild symptoms, and said that it is difficult to draw conclusions about the general administration of mild patients. It is expected that the final review committee will decide whether to recommend administration of mild patients.

As Rekironaju is expected to reduce the risk of severe progression and death when administered to mild patients in the early stages of infection, attention is focused on the final consultation results.

If the efficacy and safety are recognized in the last consultation, the Ministry of Food and Drug Safety plans to finalize the domestic use by combining the results of the consultation.