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[서울=뉴스프리존]Reporter Park Na-ri = With the number of confirmed cases of infectious disease coronavirus-19 (COVID-19) appearing in Korea every day, there is great interest in vaccines. It was announced on the 29th that a permit review had begun for the codename CT-P59).
This is due to Celltrion’s application to the Ministry of Food and Pharmaceutical Safety for an article license from Rekkirona. The Ministry of Food and Drug Safety plans to complete the approval process within 40 days.
‘Rekironaju’ is a genetically modified neutralizing antibody treatment that Celltrion is developing as a new drug.
The main component of ‘Rekirona’ is a COVID-19 neutralizing antibody that has been given the international generic name (draft) called Regdanvimab. It inserts (recombines) into host cells capable of being mass produced and is produced in large quantities through the process of cell culture.
The International Common Name (INN) is the name of a drug determined by the World Health Organization (WHO), and it is a very important step in drug development because almost all countries, including Europe and the United States, use INN. for medical prescription. Corona 19 neutralizing antibody refers to an antibody that can neutralize (neutralize) the Corona 19 virus.
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. The Ministry of Food and Drug Safety explained that by binding the antibody’s therapeutic agent to the receptor’s binding domain, it prevents the virus from penetrating the cell.
The expected 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 Corona 19 .
The Ministry of Food and Drug Safety completed the 10-month phase 2 clinical trial period through close consultation with the manufacturer from the start of development until the permit application in February.
In clinical trials, we provide recommendations to scale up target patients and expert advice so that the design of a phase 2 clinical trial that can confirm exploratory significance and therapeutic effect can be confirmed together.
Celltrion is seeking 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 is expected to 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 ‘Country of Drug Safety’ from the Ministry of Food and Drug Safety (e-civil request window, nedrug.mfds.go .kr), as in the general drug approval procedures.
The submitted data will be preliminarily reviewed by the high-tech product licensing officer, and then the experts in each field from the ‘Corona 19 Vaccine / Therapeutic Permit Deliberation Team’ organized in advance will review the necessary data to approval, 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 Celltrion’s application for product permit are non-clinical trials, clinical trials, quality, risk management plans, and manufacturing and quality management 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 Quality Management Standards (GMP) implementation status assessment data is about 10 kinds, including facility environmental management and quality assurance system related to the item for which the license is requested .
Ministry of Food and Pharmaceutical Safety
The Ministry of Food and Drug Safety said: “We will thoroughly verify safety and efficacy using experts in each field and outside experts from the ‘Corona 19 Vaccine and Treatment License Examination Team’ so that the public can use a COVID treatment. -19 safe and effective “.
He plans to test the effects of treatment, such as improving patients’ symptoms such as fever and cough, and reducing the period during which the virus passes from positive to negative, and focusing on aspects of ensuring safety and quality.
It is a policy to check directly with the clinical trial agency (medical institution) whether to comply with regulations for clinical trials in general, such as the safety of clinical trial subjects and the reliability of test results.
In addition, for this product, the GMP evaluation data was reviewed in advance before the product permit application, and the factory status survey is planned, including the results 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 request the external advice of the expert committee on treatment of COVID-19, composed of toxicologists and infectious doctors, and finally receive the advice of the Central Committee of Pharmacy Review.
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, including the product for this approval.
In accordance with the company’s request, a preliminary review of some non-clinical, quality and GMP data has been performed since November 20, and the non-clinical data has already been reviewed and data supplementation has been requested for the data. quality and GMP.
Meanwhile, the Ministry of Food and Drug Safety explained the current status of the development of COVID-19 treatments in the country and abroad.
In foreign countries, Lilly and Regeneron’s antibody therapy products are in phase 3 clinical trials and have been approved for emergency use in the United States.
Furthermore, existing drugs such as ‘baricitinib’ (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.
Celltrion is currently undergoing clinical approval for Phase 2/3 of ‘Rekirona’ from the US and Europe, and plans to move forward abroad through consultations on whether it is possible to obtain approval for emergency use (US). .) Or conditional approval (Europe) from next year. You are doing.
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 said: “If there is a permit application for a COVID-19 treatment or vaccine to be developed in the future, we will thoroughly verify the safety and efficacy and will do our best to allow approval as soon as possible. “.
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