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The Ministry of Food and Drug Safety initiates the application for conditional permission and the global permit process
Celltrion’s COVID-19 CT-P59 antibody treatment (ingredient name: Regdanvimab) has completed a phase 2 global clinical trial and submitted a request for conditional approval to the Ministry of Food and Drug Safety (hereinafter, Ministry of Food and Drug Safety).
Celltrion revealed on the 29th and at the same time announced that it will immediately begin the procedure to obtain approval for emergency use in the US and Europe based on clinical results.
This global phase 2 clinical trial was designed in consultation with the Korea Food and Drug Administration, the US FDA, and the European EMA (European Drug Administration). Days the final dosing was completed.
Celltrion concluded that the detailed data from this clinical trial were analyzed through national and foreign experts and a self-assessment, and that it had obtained sufficient grounds to request conditional approval of CT-P59 from the Ministry of Food and Drug Safety, and immediately submitted a request for approval.
However, detailed clinical data regarding the safety and efficacy of CT-P59 will be kept private until separate instructions are given at the request of the Ministry of Food and Drug Safety in view of the recent public focus on the treatment of COVID-19. It is a policy to ensure strict verification and evaluation.
The approval procedure for emergency use abroad 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 submitting applications for approval and submitting applications to most of these countries in January next year.
In addition, by responding to inquiries regarding orders from overseas government agencies, we plan to induce advance 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 approval is granted for urgent use.
A Celltrion official said: “I would like to thank the national and foreign health authorities, medical institutions and participating patients who actively supported this clinical trial as planned, and also the dozens of our employees who have dedicated themselves to work on the US and Europe. Saying.
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 for CT-P59 to be supplied to Korea as soon as possible to help as much as possible in treating Corona 19 domestic 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 the safety and efficacy across a broader group of patients.
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