[그린포스트코리아 이민선 기자] Celltrion’s Corona 19 treatment, Rekirona-ju, Rekirona-ju, has been recommended to be administered to moderate and high-risk patients with mild symptoms.
The Ministry of Food and Drug Safety (Director Kang-lip Kim) holds the’Central Pharmacy Review Committee’ meeting to advise on the safety and effectiveness of Celltrion’s antibody treatment’Recyronaju’, and allows the item to be approved under the condition of submitting the results of the phase 3 clinical trial. I asked myself that there would be.
The Central Pharmacist Review Committee meeting is a special subcommittee for deliberation on the safety and effectiveness of biopharmaceuticals, 12 standing members of the Biopharmaceutical Subcommittee, 5 verification advisories, and 18 external experts including 1 expert recommended by the Korean Medical Association and the Ministry of Food and Drug Safety. Six members, including the general review team, clinical review team, and quality review team, of the internal’Corona 19 Crisis Response Support Division’ participated.
The Ministry of Food and Drug Safety is widely collecting opinions from authoritative experts in various fields in order to secure expertise and objectivity in the approval process for COVID-19 treatment. In accordance with Article 18 of the Pharmaceutical Affairs Act, the’Central Pharmacist Review Committee’ is operated to seek advice on matters related to the safety and effectiveness of newly used drugs. In view of the severe situation of the Corona 19 pandemic, the’Corona 19 Vaccine/Therapeutic Safety and Effectiveness Verification Advisory Group’ and the’Final Inspection Committee’ are additionally formed to undergo a triple consultation process.
At this meeting of the Central Pharmacist Review Committee, we asked whether it is appropriate to recognize the safety and effectiveness of’Rekironaju’, subject to the presentation of the results of the phase 3 clinical trial after marketing. In particular, based on the safety and effectiveness review results, we asked for a comprehensive opinion of experts on the necessity of domestic use and considerations when authorizing COVID-19 treatment.
The Central Pharmacist Review Committee reviewed the safety and effectiveness of the data submitted for the application for product permission for Celltrion’Recyronaju 960mg (Regdanbimab)’, the domestic corona pandemic, and patient accessibility to the COVID-19 treatment. When considering the options of medical staff comprehensively, the need for domestic patients for the applied item was recognized, and it was advised that the item could be approved on condition that the results of the phase 3 clinical trial were submitted.
However, contrary to the opinion of the previous verification advisory group, the Central Pharmacist Review Committee recommended that this drug be administered to moderately ill patients and high-risk patients with mild symptoms because it is difficult to conclude the clinical implications of administering THIS DRUG for mild patients.
Based on the data submitted by the company regarding safety after administration of THIS DRUG, no serious life-threatening adverse events occurred at the current level, but it is necessary to conduct a phase 3 clinical trial and continuous safety evaluation after marketing for a sufficient number of patients. Advised. In the case of some members, with a few opinions, it was suggested to use special manufacturing approval rather than drug product approval.
On the other hand, the Ministry of Food and Drug Safety received and reviewed the review data, including some quality data related to Celltrion’Rexironaju’, and obtained through consultations with the’Corona 19 treatment safety and effectiveness verification advisory group’ and this’Central Pharmacy Review Committee’. Expert opinions, efficacy and effects (draft), and recommendations will be synthesized to determine whether or not to approve’Rekironaju’ through the’Final Inspection Committee’.
An official from the Ministry of Food and Drug Safety said, “We will collect various experts’ opinions in the process of reviewing the approval of the COVID-19 treatment and vaccine to ensure objectivity and transparency, while making efforts to achieve scientific approval and review.”
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