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[대전인터넷신문=종합/박완우 기자] The Ministry of Food and Drug Safety explained about the future approval process, as Celltrion Co., Ltd.’s Corona 19 treatment ‘Recyronaju 960 mg (Regdanbimab) (code name: CT-P59)’ received a request from product approval today.
(Source: Celltrion, Inc.)
Rekironaju, which was asked for permission this time, is a genetically modified neutralizing antibody treatment that Celltrion Co., Ltd. is developing as a new drug, and its main ingredient is a COVID-19 neutralizing antibody that has been given the international generic name (Regdanvimab). It is revealed that the neutralizing antibody genes present in the blood are selected and the selected and harvested genes are inserted (recombined) into host cells capable of being mass produced and produced in large quantities through the process of cell culture.
Thus, it is possible to mass-produce neutralizing antibodies using genetically recombined cells without the need to continuously collect antibodies from the blood of COVID-19 patients.
‘Becluriju’ (Remdesivir), which was previously approved as a therapeutic agent, inhibits the replication of infected Corona 19 virus in cells, while ‘Rekyronazu (Regdanvimab)’ is a human cell on the surface of Corona 19 virus. Antibody therapy binds to the binding site (receptor-binding domain) to prevent the virus from entering the cell.
The intended target patients for ‘Rekironaju’ are patients with mild to moderate corona19, and the expected dose and formulation is an injection administered intravenously over 90 minutes, and the expected efficacy and effect is the treatment of patients with mild to moderate corona19.
The Ministry of Food and Drug Safety completed the phase 2 to 10-month clinical trial period through close consultation with the manufacturer from the start of development to the permit application in February this year.
In clinical trials, we provide recommendations for scaling up target patients and expert advice so that the design of a phase 2 clinical trial that can confirm exploratory significance and therapeutic effects can be confirmed together.
Celltrion Co., Ltd. requests approval after completing phase 2 of the multinational clinical trials approved by the Ministry of Food and Drug Safety at the same time, and phase 3 will proceed as planned regardless of this request.
Phase 2 aims to shorten the recovery period for 7 corona19 symptoms, such as fever, in 327 mild to moderate Corona19 patients, and shorten the time it takes to transition from positive to negative during virus testing.
Phase 3 plans to verify whether the rate of worsening symptoms, such as the need for oxygen treatment or hospitalization, for 720 patients with mild to moderate Corona 19 decreases.
This approval / review started when Celltrion, a manufacturer, submitted the application for approval and related data to the Department of Drug Safety of the Ministry of Food and Drug Safety Nara, as well as the general drug approval procedure.
After the submitted data is preliminarily reviewed by the Hi-Tech Product Licensing Officer, experts in each field from the ‘Crown Vaccine / Therapeutic Permit Deliberation Team 19’ organized in advance will review the data. required for approval, such as non-clinical, clinical, and quality.
The review opinions are then synthesized to determine the validity of the permit, and final approval is granted through consultation with the Central Pharmacy Review Committee comprised of external experts.
The primary data reviewed by the Celltrion Co., Ltd. product authorization application are non-clinical trials, clinical trials, quality, risk management plans, and manufacturing and quality control data.
Non-clinical test data is data that verifies toxicity and efficacy through animal testing prior to drug administration to humans, and clinical test data is data that confirms safety and efficacy when administered to humans.
Quality data is data on the management of the drug manufacturing process and the “ standards and test methods ” for quality control, and the risk management plan (RMP) includes comprehensive risk mitigation measures, as instructions for use for patients and measures to ensure safe use. These are data about the security management plan.
Manufacturing and Quality Management Standards (GMP) Implementation Status Assessment Data is 10 types of data, including quality assurance and environmental and facility management systems related to the item for which the item is requested. Excuse me.
The Ministry of Food and Pharmaceutical Safety announced that it will thoroughly verify safety and efficacy by using experts in each field and outside experts from the ‘Corona 19 Vaccine and Treatment Licensing Exam Team’ so that the public can use a treatment. COVID-19 safe and effective.
He plans to check the effects of the treatment, such as improving the patient’s symptoms, such as fever and cough, and reducing the period during which the virus goes from positive to negative, and focusing on aspects of ensuring safety and quality.
Please check directly with the clinical trials agency (medical institution) whether or not you should comply with regulations for clinical trials in general, such as the safety of clinical trial subjects and the reliability of test results.
This product has undergone a preliminary review of GMP evaluation data prior to applying for an item license, and you plan to conduct a factory condition survey, including the result of the preliminary review.
To ensure the professionalism and objectivity of the evaluation results, we plan to provide external expert advice. Regarding the validity of the data presented for the review and acceptance of the permit in the clinical field, we plan to seek the external advice of the advice of experts in the treatment of COVID-19 composed of specialists such as toxicologists and specialists in infectious medicine, and finally receive the advice of the Central Pharmacy Review Committee. .
The Ministry of Food and Drug Safety plans to grant permission on the condition that the results of the currently ongoing phase 3 clinical trial are submitted after approval if the safety and efficacy are sufficiently confirmed as a result of the review of approval and expert consultation for the applied product.
The Ministry of Food and Drug Safety aims to shorten the existing processing period (180 days or more) and process it within 40 days for rapid approval and review of the Corona 19 vaccine and treatment products, including the product for this approval.
According to the company’s request, a preliminary review was performed for some non-clinical, quality, and GMP data (11.20 ~), and the non-clinical data had already been reviewed and data supplementation was requested for the data. quality and GMP.
Regarding the development of COVID-19 treatment at home and abroad, Lily and Regeneron’s antibody treatments are in phase 3 clinical trials, and approval for urgent use was obtained in the United States.
Furthermore, existing drugs such as ‘varicitinib’ (arthritis treatment) are also undergoing clinical trials to add the efficacy and effect of Corona 19 treatment.
In Korea, clinical trials are underway for a total of 15 products (13 ingredients), including ‘Rekironaju’ and the antibody treatments that are being developed as a treatment for Corona 19.
Currently Celltrion Co., Ltd. has been approved for phase 2/3 clinical trials in the United States and Europe for ‘Rekirona’. Planning.
This product is the third product to have sought approval from licensing authorities after Lily and Regeneron among COVID-19 antibody treatments competing for development worldwide.
The Ministry of Food and Drug Safety announced that it will thoroughly verify the safety and efficacy of the COVID-19 treatment / vaccine, which will be developed in the future, and allow approval as soon as possible.
Reporter Park Wan-woo
