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Antibody treatment “ Recyrona (ingredient name Regdanvimab) ” developed by Celltrion for novel coronavirus (Corona 19) infection is recommended for conditional approval by the “ Drug Safety and Efficacy Verification Advisory Group Corona 19 ” received.
Director Lee Dong-hee of the Korea Food and Drug Administration (KFDA) released the results of the meeting of the Central Pharmaceutical Review Committee (hereinafter “ Central Drug Review ”) of the Ministry of Food and Drug Safety on the conditional approval of “ Rekkirona ” on the 27th.
The Ministry of Food and Pharmaceutical Safety held a meeting of the Central Committee for Pharmaceutical Affairs at 2:00 p.m. on the same day at the headquarters of the Ministry of Food and Pharmaceutical Safety in Osong, Chungcheongbuk-do, to advise on the safety and efficacy of ‘Rekkirona ‘.
This meeting of the central pharmacy review committee is a special subcommittee for biopharmaceutical review, 12 permanent members of the Biopharmaceutical Subcommittee, 5 verification advisory members and 1 expert recommended by the Korean Medical Association, and 18 external experts and internal staff of the Ministry of Health. Food and Drug Safety. Corona Crisis Response 19. The Biotherapy General Review Team, Clinical Review Team, and Support Division Quality Review Team attended.
Director Lee Dong-hee said: “The Ministry of Food and Drug Safety is gathering a wide range of opinions from authoritative experts in various fields to ensure expertise and objectivity in the approval process for COVID-19 treatments.” . In accordance with article 18 of the ‘Pharmaceutical Affairs Law’, the ‘Central Pharmacy Review Committee’ is being operated to seek advice. In consideration of the serious situation of the Corona 19 pandemic, the ‘Vaccine Safety and Efficacy Verification Advisory Group /’ Final Inspection ‘Treatment “The committee has been formed to go through a triple consultation process”, explained.
Director Lee said: “At this meeting of the Central Pharmacy Review Committee, we asked whether it is appropriate to acknowledge safety and efficacy under the condition of presenting the results of a phase 3 clinical trial for ‘Rekirona’ post-marketing.” . Regarding the results of the gender review, we consulted the expert’s comprehensive opinion on the need for domestic use and the considerations when licensing as a treatment for COVID-19.
The result of the consultation was announced by Professor Yu-hwan (Catholic University of Medicine), who was the president of Central Yak-Shim.
Professor Yu-hwan said: “The Central Pharmacy Review Committee reviewed the safety and efficacy of the data submitted by Celltrion for the product permit application for ‘Reccyrona’, the domestic corona pandemic situation, the access of patients to Corona 19 treatment and medical personnel. “When considering the product options comprehensively, the need for domestic patients for the applied article was recognized, and it was reported that the article could be approved under the condition of presenting the results Phase 3 Clinical Trial “.
Prof. Oh said: “However, contrary to the opinion of the previous verification advisory group, the Central Pharmacy Review Committee decided that it was difficult to conclude the clinical importance of the administration of this drug for ‘mild’ patients, and recommended its use in a limited group of patients. “” We recommend that this drug be administered to moderate and high risk patients with mild symptoms. “
In addition, “In terms of safety, there have been no serious, life-threatening cases at the current level according to the data presented by the company, but it is recommended that a phase 3 clinical trial and continuous safety evaluation after marketing are required for a “However, in the case of some members of the opinion, it was suggested to use ‘special manufacturing approval’ instead of pharmaceutical product approval,” he said.
As a result, the recommended efficacy and effect of ‘Recirona’ core weakness is ▲ oxygen saturation in indoor air exceeds 94% ▲ No supplemental oxygen supply required ▲ High risk groups with symptoms within 7 days prior to administration, mild and moderate It is the improvement of clinical symptoms in adult patients with COVID-19 (older than 18 years).
On this day, Director Lee Dong-hee also said: “The Ministry of Food and Drug Safety will also reflect the recommendations of the Central Pharmacopoeia (rather than the recommendations of the verification advisory group) for the use guidelines of ‘Rekkirona ‘ in the future.”
In the future, the Ministry of Food and Drug Safety will receive review data, as part of the quality data related to ‘Recyrona’ for review, and will comprehensively review expert opinions, efficacy, effects and recommendations obtained through consultation with the verification advisory group. and the Central Pharmacopoeia. Through the ‘Committee’, a final decision on whether or not to approve ‘Rekirona is scheduled.
