For a total of 1300 people… Data analysis, results derivation, and submission target by the end of June
Celltrion announced on the 26th that it has completed recruiting and administering patients for phase 3 clinical trials of’Rekirona’, a corona19 antibody treatment.
Celltrion has been registering patients for phase 3 clinical trials since January, and recently, 13 countries including Korea, the United States, Spain, and Romania.In total, a total of 1300 patients with the target of phase 3 clinical trials were recruited and medication was completed.
Celltrion initially conducted phase 3 global clinical trials with 1,172 people, but in order to secure safety and efficacy results from more patients, the final recruitment number was confirmed to be 1300.
To date, there have been no specifics in terms of safety among patients who have completed the medication. In addition, there were no cases of discontinuation of the study due to adverse reactions after dosing.
Celltrion plans to actively emphasize the safety of Rekirona in the ongoing export discussions, and to draw data analysis and results for phase 3 clinical trials by the end of June and submit them to domestic and overseas licensing agencies.
Celltrion expects that this will speed up the screening process for current permit applications.
Celltrion was a conditional treatment for patients with mild and moderate symptoms in high-risk groups who are 60 years of age or older or have an underlying disease (cardiovascular disease, chronic respiratory system disease, diabetes, or hypertension) from the Ministry of Food and Drug Safety in February. Obtained approval.
As Celltrion is conducting a large-scale global clinical phase 3 in this phase 3, it is predicted that if the safety and efficacy of Rekirona is proven, the target group for administration will be expanded.
Celltrion has already completed the production of Rekirona for 100,000 people last year, and is equipped with a system that can additionally produce Rekirona for 1.5 to 3 million people per year depending on global demand.
An official from Celltrion said, “The corona19 virus is still prevalent in many global countries, and with the great efforts of the head office clinical team and local staff, it was possible to recruit a sufficient number of patients in a short time.” In anticipation, we will concentrate our capabilities to derive excellent results through phase 3 clinical data analysis in the first half of this year.”
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