Celltrion-developed novel coronavirus infection (Corona 19) antibody treatment “Reckirona (ingredient name Regdanvimab)” is recommended for conditional approval from the “Corona 19 Drug Safety and Effectiveness Verification Advisory Group” Received.
Director Lee Dong-hee of the Korea Food and Drug Administration (KFDA) released the results of the Central Pharmacist Review Committee (hereinafter referred to as “Central Drug Review”) meeting of the Ministry of Food and Drug Safety on the conditional approval of “Rekkirona” on the 27th.
The Ministry of Food and Drug Safety held a meeting of the Central Pharmaceutical Affairs Committee at 2 pm on the same day at the headquarters of the Ministry of Food and Drug Safety in Osong, Chungcheongbuk-do, to advise on the safety and effectiveness of’Rekkirona’.
This central pharmacy review committee meeting is a special subcommittee for biopharmaceutical review, 12 standing members of the Biopharmaceutical Subcommittee, 5 verification advisory groups, and 1 expert recommended by the Korean Medical Association, and 18 outside experts and the Ministry of Food and Drug Safety’s internal’corona 19 crisis response. The support division’s biotherapy review team’s overall review team, clinical review team, and quality review team attended.
Director Lee Dong-hee said, “The Ministry of Food and Drug Safety is collecting a wide range of opinions from authoritative experts in various fields in order to secure expertise and objectivity in the approval process for COVID-19 treatments.” In accordance with Article 18 of the’Pharmaceutical Affairs Act’, the’Central Pharmacy Review Committee’ is being operated to seek advice.In consideration of the severe situation of the COVID-19 pandemic, the’Corona 19 Vaccine/Therapeutic Safety and Effectiveness Verification Advisory Group’ and’final inspection’ “The committee has been formed to go through a triple consultation process,” he explained.
Director Lee said, “At this meeting of the Central Pharmacy Review Committee, we asked ourselves whether it is appropriate to recognize the safety and effectiveness under the condition of submitting the results of a phase 3 clinical trial for’Rekirona’ after marketing.” Based on the results of the gender review, we consulted the expert’s comprehensive opinion on the necessity of domestic use and considerations when licensing as a COVID-19 treatment.”
The result of the consultation was announced by Professor Yu-hwan (Catholic University of Medicine), who was the chairman of the Central Yak-Shim.
Prof. Yu-hwan said, “The Central Pharmacy Review Committee reviewed the safety and effectiveness of the data submitted by Celltrion for the application for product permission for’Recyrona’, the domestic corona pandemic situation, patient access to the Corona 19 treatment, and medical staff. “When considering the options of the product comprehensively, the need for domestic patients for the applied item was recognized, and it was advised that the item could be approved under the condition of submitting the results of the 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 significance of this drug administration for’mild’ patients, and recommended it to be used in a limited group of patients.” “We recommend that this drug be administered to patients with moderate and high-risk patients with mild symptoms.”
In addition, “Regarding safety, there have been no serious life-threatening cases at the current level based on the data submitted by the company, but it is recommended that a phase 3 clinical trial and continuous safety evaluation after marketing are necessary for a sufficient number of patients. “However, in the case of some committee members, it was suggested to use’special manufacturing approval’ rather than drug product approval,” he said.
As a result, the recommended efficacy and effect of the central weakness for’Recyrona’ is ▲the oxygen saturation in indoor air exceeds 94% ▲No supplementary oxygen supply is 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 (over 18 years of age).
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 guidelines for use of’Rekkirona’ in the future.”
In the future, the Ministry of Food and Drug Safety will receive review data such as part of the quality data related to’Recyrona’ for review, and comprehensively review expert opinions, efficacy, effects, and recommendations obtained from the verification advisory group and the Central Pharmacy Review Through the’Committee’, the final decision is to be made on whether or not to approve’Rekirona’.