Reporter Seo Yoon-Seok, Bio Spectator
Unlike the verification advisory group, patients with mild corona19 are excluded..Recommendation of administration to mild corona19 patients in moderate and high-risk groups over 18 years of age..Decision on final approval after the final inspection committee
The Ministry of Food and Drug Safety said at a meeting of the’Central Pharmacist Review Committee (Central Drug Review Committee)’ that it recommended product approval on the premise of conducting phase 3 clinical trials for Celltrion’s Corona 19 antibody’Rekironazu’.
However, the Central Pharmaceutical Affairs Committee recommended that Rekyrona injection be administered to patients with mild corona19 in moderate and high-risk groups over the age of 18. Contrary to the opinion of the last verification advisory group, the Central Pharmacopoeia concluded that it is difficult to conclude the clinical significance of the administration of Rekirona injection to mild Corona 19 patients.
The Ministry of Food and Drug Safety received and reviewed the review data, including part of Celltrion’s quality data related to’Rekironaju’, while reviewing it through consultations with the’Corona 19 treatment safety and effectiveness verification advisory group’ and the’Central Pharmacy Review Committee’ After taking the opinions together, it will go through the’Final Inspection Committee’ and finally decide whether or not to approve the’Rekirona state’.
The Ministry of Food and Drug Safety announced through an online briefing that it received the results of the Central Pharmacy Review Committee meeting at 7 pm on the 27th. The Central Pharmacy Review Committee was held at 2 pm on the same day at the headquarters of the Food and Drug Administration in Osong, Chungcheongbuk-do to advise on the safety and effectiveness of Rekkirona.
This central pharmacy review committee meeting was held with 18 external experts including 12 standing members of the Biopharmaceutical Subcommittee, 5 verification advisory members, and 1 expert recommended by the Korean Medical Association for deliberation on the safety and effectiveness of biopharmaceuticals. Six members, including the general review team, clinical review team, and quality review team, of the internal’Corona 19 Crisis Response Support Division’ attended the biotherapy review team.
As a result, the Central Pharmaceutical Affairs Committee advised that the need for domestic patients in Rekirona could be acknowledged, and that the product could be approved subject to the submission of the results of phase 3 clinical trials. This is the result of comprehensive consideration of the safety and effectiveness of the data submitted by Celltrion for the application for product permission of Rekkirona, the domestic Corona 19 pandemic, patient access to Corona 19 treatment, and the choice of medical staff.
In addition, based on the data submitted by Celltrion regarding safety after administration of Rekirona, there have not been any serious life-threatening cases to date, but it is recommended that continuous safety evaluation after phase 3 clinical trials and after marketing is required for a sufficient number of patients. did.
The recommended efficacy and effects of the Central Pharmaceutical Affairs Commission are as follows.
◇Improvement of clinical symptoms in adult patients with mild novel coronavirus infection (18 years of age or older) in moderate and high-risk groups that meet the following criteria
1) Persons whose oxygen saturation exceeds 94% in indoor air
2) Those who do not need an auxiliary oxygen supply
3) Those who develop symptoms within 7 days before administration