[현장연결] Ministry of Food and Drug Safety “Recyrona state approval… expected to overcome Corona 19 and return to daily life”
The Ministry of Food and Drug Safety is announcing the results of the final inspection committee meeting for Celltrion’s Corona 19 antibody treatment’Rekironaju’.
Let’s hear it yourself.
[김강립 / 식품의약품안전처 처장]
The Ministry of Food and Drug Safety held a final inspection committee consisting of external experts today to grant approval of the item under the condition of submitting the results of phase 3 clinical trials for the Corona 19 antibody treatment Rekirona, which Celltrion Co., Ltd. applied for permission on December 29, 2020. I decided.
Rekirona is a gene-manufacturing neutralizing antibody treatment that is made through cell culture by recombining the neutralizing antibody gene present in the blood of the cure.
The efficacy of this product is to improve clinical symptoms in adult patients with mild to moderate corona19 in high-risk groups, and it is an injection in which 40ml is injected intravenously per 1 kg of adult weight.
Rekironaju is the first corona19 treatment approved by domestically developed drugs and the third corona19 antibody treatment approved by regulatory authorities in the world.
With this permission, if Rekirona is used in medical fields where treatment is urgent in the situation of the Corona 19 pandemic, it is expected that it will play a meaningful role in overcoming Corona 19 and returning to daily life along with vaccines to be vaccinated in Korea.
In addition, if the clear effect of this drug is confirmed through a phase 3 clinical trial in the future, it will not only be used appropriately for patient treatment, but it will also help to relieve the difficulties of securing critically ill beds in quarantine and medical fields.
On December 29, 2020, the Ministry of Food and Drug Safety received an application for product permission in Rekirona, and made a thorough review based on scientific grounds, putting safety first.
The safety and effectiveness verification period has been secured as much as possible by reviewing data that can be reviewed in advance before the application for permission for this product is received.
The COVID-19 treatment approval team, composed of the best experts in each field within the Ministry of Food and Drug Safety, intensively reviewed the data necessary for the approval.
In addition, in order to evaluate whether the quality of this product is equipped with a facility and a management system that can be consistently produced, a field survey was conducted at the factory, and a survey of the clinical trial agency was conducted to confirm the safety of clinical trial subjects and the reliability of the test results. Also proceeded.
In addition to consulting the Central Pharmacy Review Committee, which is the legal advisory body of the Ministry of Food and Drug Safety, in order to increase expertise and objectivity in the approval process of the COVID-19 treatment, the Ministry of Food and Drug Safety has additionally formed an advisory group to verify the stability and effectiveness of the Corona 19 treatment and a final inspection committee. It went through the verification process.
On January 17th, we received advice from the Verification Advisory Group on whether the therapeutic effect and safety of the results of the clinical trial of Rekirona were appropriate.
On January 27, we received advice from the Central Pharmacist Review Committee on whether it is appropriate to recognize the safety and effectiveness of Rekkirona as a condition for submitting the results of the phase 3 clinical trial after marketing.
And today at 10 am, the Ministry of Food and Drug Safety held a final inspection committee to decide whether to approve items for Rekkirona.
Three members of the Central Pharmacy Review Committee and five experts from the Ministry of Food and Drug Safety participated in today’s meeting, which is the final stage of the COVID-19 treatment approval review.
The Central Pharmacy Review Committee comprehensively respected the paragraphs of the previous two consultations and the opinions of the Central Pharmacy Review Committee, and decided to grant the product of Rekkirona, subject to the submission of the results of phase 3 clinical trials.
In addition, the range of use of this drug was finalized for high-risk patients with mild to moderate severity.
The Ministry of Food and Drug Safety plans to manage the phase 3 clinical trials faithfully even after the product is approved, and will cooperate with relevant ministries so that side effects can be thoroughly monitored in the use process and used safely for patients who are indispensable in the clinical field. .
Thank you.
Yonhap News TV article inquiries and reports: katok/line jebo23
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