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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 this clinical result, the procedure to obtain approval for emergency use in the US and Europe will be started immediately.
According to Celltrion on day 29, this global phase 2 clinical trial was designed through prior consultation with the Korean Food and Drug Administration, the United States FDA (Food and Drug Administration) and the EMA (European Administration of Medicines) of Europe. Participated and completed final medication on November 25.
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.
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Celltrion is also promoting the CT-P59 overseas emergency use approval procedure. 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 “. said.
