After safety/effectiveness verification… Target of treatment within 40 days
The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced on the 29th that Celltrion has received an application for product permission for the COVID-19 treatment “Recyronaju 960mg (Regdanbimab) (code name: CT-P59).
Accordingly, the Ministry of Food and Drug Safety is planning to decide whether to approve it after verifying its safety and effectiveness within 40 days.
According to the Ministry of Food and Drug Safety, Rekirona is a genetically modified neutralizing antibody treatment being developed as a new drug by Celltrion.
Neutralizing antibody genes present in the blood of a cure for Corona 19 are selected, and the collected genes are inserted (recombined) into host cells capable of mass production, and then mass-produced through the cell culture process.
Therefore, 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.
The expected target patients of Rekirona are mild to moderate corona19 patients, and the expected dosage and formulation is an injection that is administered intravenously for 90 minutes, and the expected efficacy and effect is the treatment of mild to moderate corona19 patients.
The Ministry of Food and Drug Safety said, “In February of this year, through close consultation with the manufacturer from the beginning of development to the application for permission, the phase 2 clinical period was significantly shortened to 10 months.” “In clinical trials, exploratory meaning and therapeutic effects can be confirmed together. We provided recommendations for expanding target patients and providing expert advice so that they could be designed for phase 2 clinical trials.”
“Celltrion is to complete phase 2 and apply for permission among multinational clinical trials that have been approved by the Ministry of Food and Drug Safety at the same time,” he explained. “Phase 3 will proceed as planned, regardless of this application.” did.
In the clinical course of Rekirona, Phase 2 was confirmed to shorten the recovery period for 7 corona19 symptoms, including fever, for 327 mild to moderate corona19 patients, and to shorten the time it takes to transition from positive to negative during virus testing. I aimed to do.
In the third phase, it is planned to check whether the rate of worsening symptoms such as needing oxygen treatment or hospitalization for 720 mild to moderate Corona 19 patients decreases.
The Ministry of Food and Drug Safety said, “This approval/application started with Celltrion, a manufacturer, submitting the approval application and related data to the Ministry of Food and Drug Safety, as in general drug approval procedures,” said the Ministry of Food and Drug Safety. After the preliminary examination, experts in each field of the’Corona 19 Vaccine/Therapeutic Product Authorization Evaluation Team’ organized in advance will examine the data necessary for the approval such as non-clinical, clinical, and quality.”
He then explained, “It is possible to determine the validity of the approval by synthesizing the opinions of the review, and to give the final approval after consulting the Central Pharmacy Review Committee composed of external experts.”
The data used for approval and review by the Ministry of Food and Drug Safety include non-clinical tests, clinical tests, quality, risk management plans, and manufacturing and quality control data.
The Ministry of Food and Drug Safety said, “We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of the’Corona 19 Vaccine and Treatment License Examination Team’ so that safe and effective COVID-19 treatment can be used by the public.”
In addition, he said, “We plan to check treatment effects such as improving patient symptoms such as fever and coughing, and reducing the period during which the virus transitions from positive to negative, and focus on the aspects of securing safety and quality.” “Securing expertise and objectivity of the evaluation results In order to do so, we plan to consult with external experts.”
It is planned to request external advice from the COVID-19 treatment expert consultative body consisting of specialists such as toxicologists and infectious medicine specialists regarding the validity of the data submitted for the permit review and acceptance in the clinical field, and finally receive advice from the Central Pharmacy Review Committee. Description.
On the other hand, the Ministry of Food and Drug Safety said, “If safety and effectiveness are sufficiently confirmed as a result of the approval review and expert consultation, we plan to grant permission on the condition that the results of the currently ongoing phase 3 clinical trial are submitted after approval.” It aims to shorten the existing treatment period (180 days or more) and process it within 40 days for the rapid approval and review of the Corona 19 vaccine and treatment.”
In addition, he added, “If there is an application for permission for a COVID-19 treatment or vaccine that will be developed in the future, we will thoroughly verify the safety and effectiveness, and do our best to allow approval as quickly as possible.”
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