Global clinical phase 2 progressed smoothly… Submitted application for conditional permit from the Ministry of Food and Drug Safety today
Based on clinical results, consultations with FDA and EMA commenced to apply for emergency use approval in the US and Europe in January
Details of the results of phase 2 will be announced through the international conference
Celltrion completed phase 2 of the global clinical trial of CT-P59 (ingredient name: Regdanvimab), a corona19 antibody treatment, as originally planned, and submitted an application for conditional approval to the Ministry of Food and Drug Safety (“MFDS”) today. did. At the same time, based on the clinical results, the procedure for obtaining emergency use approval in the US and Europe will be immediately initiated.
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.
Celltrion is also pursuing an overseas emergency use approval procedure for CT-P59. 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.
In addition, “We plan to accelerate the overseas approval process while responding to all inquiries and requests from the Food and Drug Administration 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.” Through this, I hope that CT-P59, like the ingredient name’Regdanbimab’, will be a raindrop of hope to the people around the world who eagerly wish to end the Corona 19 pandemic.”
Meanwhile, Celltrion plans to present the results of this phase 2 clinical trial in detail at an international conference soon. In addition, based on the results, it is planned to begin phase 3 clinical trials in 10 countries around the world as soon as possible to further verify the safety and efficacy of CT-P59 through a broader patient group.
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