Celltrion announced that it has completed phase 2 of the global clinical trial of CT-P59 (ingredient name Regdanvimab), a corona19 antibody treatment, and submitted an application for conditional approval to the Ministry of Food and Drug Safety on the 29th. 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 clinical trial was designed through prior consultation with the Korea Food and Drug Administration, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA), and a total of 327 patients from Korea, Romania, Spain and the United States participated and finalized on November 25. Dosing is complete.
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. While sharing the data on the results of this phase 2 clinical trial in detail with the FDA and EMA, consultations regarding the submission of applications for approval will be initiated, and applications will be submitted 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 an emergency use approval is issued.
An official from Celltrion said, “We are grateful to the domestic and foreign health authorities, medical institutions, and patients who have actively supported this clinical trial as planned, and to the dozens of our employees who have devoted themselves to the work in the US and Europe.” Revealed.
“We plan to speed up the overseas approval process while responding to all inquiries and requests from the KFDA 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.