Celltrion completed phase 2 of the global clinical trial of CT-P59 (ingredient name: Regdanbimab), a corona19 antibody treatment, and today submitted an application for conditional approval to the Ministry of Food and Drug Safety. 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.
According to Celltrion on the 29th, this global phase 2 clinical trial was designed through prior consultation with the Korean Food and Drug Administration, the US FDA (Food and Drug Administration), and the European EMA (European Drug Administration). Participated and completed the final medication on November 25th.
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.
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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 patients who actively supported this clinical trial as planned, and to the dozens of our employees who have dedicated themselves to the work in the US and Europe.” said.