Ministry of Food and Drug Safety initiates conditional permit application and global permit process
Celltrion’s COVID-19 antibody treatment CT-P59 (ingredient name: Regdanvimab) has completed a global clinical phase 2 trial and submitted an application for conditional approval to the Ministry of Food and Drug Safety (hereinafter the Ministry of Food and Drug Safety).
Celltrion announced on the 29th that at the same time, based on the clinical results, it will immediately begin the procedure for obtaining approval for emergency use in the US and Europe.
This global phase 2 clinical trial was designed through prior consultation with the Korea Food and Drug Administration, the US FDA (Food and Drug Administration), and the European EMA (European Drug Administration), and a total of 327 patients from Korea, Romania, Spain and the United States participated in November 25. Days final dosing was completed.
Celltrion concluded that the detailed data of this clinical trial were analyzed through domestic and foreign experts and self-evaluation, and that it had secured sufficient grounds for applying for CT-P59 conditional approval from the Ministry of Food and Drug Safety, and immediately submitted an application for approval.
However, detailed clinical data related to the safety and efficacy of CT-P59 will be kept private until separate instructions are made at the request of the Ministry of Food and Drug Safety in view of the recent focus of the public on COVID-19 treatment. It is a policy to secure strict verification and evaluation.
The overseas emergency use approval procedure is also promoted. By sharing the data on the results of this phase 2 clinical trial in detail with the US FDA and the European Medicines Agency (EMA), the company plans to initiate consultations on the submission of approval applications and submit applications to most of these countries in January next year.
In addition, when responding to inquiries related to orders from overseas government agencies, we plan to induce pre-orders by explaining the results of this phase 2 clinical trial in detail so that they can be supplied in Korea as soon as possible as soon as urgent use approval is granted.
An official from Celltrion said, “I would like to thank the domestic and foreign health authorities, medical institutions, and participating patients who actively supported this clinical trial as planned, and also to the dozens of our employees who have devoted themselves to working in the US and Europe.” Told.
He added, “We plan to speed up the overseas approval process while responding to all inquiries and requests from the Ministry of Food and Drug Safety during the review period so that CT-P59 will be supplied to Korea as soon as possible to help the most in the treatment of domestic Corona 19 patients.”
On the other hand, Celltrion announced that it plans to announce the results of this phase 2 clinical trial in detail at an international conference in the near future, and also enter phase 3 clinical trials in 10 countries around the world, further verifying safety and efficacy through a broader patient group.
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