“Conditional approval plan for submitting the results of phase 3 clinical trials when safety and effectiveness are verified”
Celltrion “Starting the US-European emergency use approval procedure at the same time as domestic application”
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(Seoul = Yonhap News) Reporter Jandi Kim = Celltrion from Ministry of Food and Drug Safety[068270]On the 29th, it announced that it has undertaken a license review for the antibody treatment drug’Recyronaju’ (ingredient name regdanvimab, code name CT-P59) for a novel coronavirus infection (Corona 19).
This is due to Celltrion’s application to the Ministry of Food and Drug Safety for an item license of Rekkirona. Until now, Celltrion has revealed that it will apply for permission for Corona 19 antibody treatment within this year. This is the third case of applying for approval to the licensing authorities after Lily and Regeneron among the COVID-19 antibody treatments being developed around the world.
Celltrion applied for permission from the Korean Food and Drug Administration, and at the same time initiated procedures to obtain emergency use approval in the United States and Europe.
Rekironaju is an antibody treatment product made by selecting neutralizing antibodies present in the blood of a cure for Corona 19. It is developed as an injection that is administered intravenously for about 90 minutes to patients with mild to moderate levels of Corona 19.
It is produced through the process of mass-producing by selecting neutralizing antibody genes that neutralize the Corona 19 virus from the blood of a cure for Corona 19, and inserting (recombining) the selected and collected genes into host cells capable of mass production. Accordingly, 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.
Already in some sites, two cases are being prescribed after receiving approval for treatment purposes from the Ministry of Food and Drug Safety, apart from clinical trials or conditional approval. On the 11th of this month, Asan Hospital in Seoul and the Sanggye Paik Hospital of Inje University on the 22nd of this month were approved for use for treatment purposes.
The Ministry of Food and Drug Safety is operating a treatment-purpose use approval system that allows users to use drugs for clinical trials that are not licensed for the treatment of severe, life-threatening patients or other treatment means. You can apply for a hospital to use the drug to treat a specific patient.
Phase 2 clinical trials were conducted in Romania, Spain, and the United States, including Korea, targeting 327 mild to moderate corona19 patients with the aim of shortening the recovery period for corona19 symptoms such as fever. Celltrion plans to present the results of phase 2 clinical trials at an international conference in the near future.
Celltrion said that it has determined that it has secured sufficient grounds for applying for conditional permission to the Ministry of Food and Drug Safety as a result of self-evaluation and analysis of the clinical results.
In phase 3 clinical trials, 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 in 10 countries around the world decreases. This application is separate from the application.
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The Ministry of Food and Drug Safety plans to thoroughly verify the safety and effectiveness of the drug by using the’Corona 19 vaccine/treatment approval review team’.
While improving the symptoms of corona19 patients and reducing the period during which the diagnosis result is converted from positive to negative, it is decided to focus on the aspects of securing safety and quality while confirming the treatment effect. Finally, it plans to receive the advice of the Central Pharmacy Review Committee.
After that, if the safety and effectiveness are sufficiently confirmed, it plans to grant permission on condition that the results of the ongoing phase 3 clinical trial are submitted after approval. The review of non-clinical data has already been completed. The goal is to complete the approval process within 40 days.
Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said, “In the case of Corona 19 vaccines and treatments, we are pursuing the goal of shortening the existing approval review processing period of 180 days or more and processing them within 40 days.”
An official from Celltrion said, “We are grateful to the domestic and foreign health authorities, medical institutions, and participating patients who have actively supported this clinical trial to end smoothly as planned.” We will respond faithfully and promptly to all inquiries and requests from the Ministry of Food and Drug Safety during the examination as much as possible.”
Currently, clinical trials for a total of 15 products, including Rekirona, are in progress in Korea.
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2020/12/29 15:10 sent