Celltrion filed a conditional permission application with the Ministry of Food and Drug Safety on Dec. 29, completing the second phase of global clinical trial of the COVID-19 antibody treatment CT-P59 (Regdanvimab) as originally planned.
At the same time, the company will immediately start a process to obtain approval for emergency use in the U.S. and Europe based on this clinical result.
The second global clinical trial was designed through prior consultations with the Korean Food and Drug Administration, the U.S. Food and Drug Administration (FDA), and the European EMA (European Medicines Agency), and a total of 327 patients participated in the final injection on November 25.
Celltrion immediately submitted an application for permission, judging that it had sufficient evidence to complete the analysis of the detailed data of the clinical trial through domestic and foreign experts and self-evaluation and apply for conditional permission to the Ministry of Food and Drug Safety for CT-P59.
However, detailed clinical data related to the safety and efficacy of CT-P59 shall be kept private until further instructions are provided at the request of the Ministry of Food and Drug Safety, considering that the public's attention has recently been focused on the COVID-19 treatment.
Celltrion will also push for an emergency approval process for CT-P59 overseas. It is planning to start consultations on submitting applications for approval with the U.S. FDA and the EMA and submit applications to most of these countries in January next year.
An official from Celltrion said, "We thank domestic and foreign health authorities, medical institutions, and participating patients who actively supported the clinical trial to end smoothly as originally planned, and we also thank dozens of our employees who have worked in the U.S. and Europe."
Meanwhile, Celltrion plans to announce the results of its second phase of clinical trial in detail at an international conference soon. Based on the results, the third phase of clinical trials will be launched as soon as possible in more than 10 countries around the world to further verify the safety and efficacy of CT-P59 through a wider range of patients.
