KFDA points out issues of effectiveness and clinical design
Chong Kun Dang “Proven drug efficacy through phase 3 clinical trials as planned”
[서울=뉴스핌] Reporter Jeong Seung-won = Chong Kun Dang is accelerating the phase 3 clinical trial of’Napa Beltan’, which is being developed as a treatment for the novel coronavirus infection (Corona 19). As they have not received approval from the Ministry of Food and Drug Safety recently, they are determined to prove the therapeutic effect in phase 3 clinical trials and challenge formal approval.
According to Chong Kun Dang on the 18th, the Ministry of Food and Drug Safety held a verification advisory committee meeting on Napa Beltan on the 17th and said,’We have not been able to confirm the effectiveness of Corona 19 treatment.’
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| Chong Kun Dang’Napa Beltan’ [자료=종근당] |
It is judged that it is difficult to recognize the therapeutic effect of Napa Beltan based on the results of the phase 2 clinical trial submitted by Chong Kun Dang for product approval.
The submitted clinical trial data was one phase 2 clinical trial conducted in Russia, and was conducted on 104 patients at 13 clinical trial institutions in Russia.
The clinical trial was divided into a group of patients receiving standard treatment for COVID-19 (control group, 51 patients) through an open/random assignment method, and a group of patients receiving standard treatment and test drugs (test group, 53 patients).
As a result of the evaluation, the clinical improvement time was 11 days for both the test group and the control group, and there was no significant difference, and the time for the virus test result to change from positive to negative was also 4 days.
The early warning score evaluated based on seven clinical variables showed some significant effects, but it was concluded that the effectiveness could not be confirmed because the trial design was different from what was planned.
In the end, the Ministry of Food and Drug Safety decided not to hold the Central Pharmacopoeia, which is the second stage of the triple verification system leading to the Verification Advisory Committee, Central Pharmacy Review Committee, and Final Inspection Committee, and that it will support Chong Kun Dang to faithfully carry out phase 3 clinical trials of Napaveltan Stated the policy.
An official from the Ministry of Food and Drug Safety said, “We will collect various experts’ opinions in the process of reviewing the approval of COVID-19 treatments and vaccines to ensure objectivity and transparency, while ensuring thorough approval and review.”
As Chong Kun Dang also failed to prove the effectiveness of Napabeltan in phase 2 clinical trials, it plans to reverse the point by supplementing the points pointed out in phase 3 clinical trials.
An official from Chong Kun Dang said, “We plan to conduct a phase 3 clinical trial as planned to prove the efficacy of the drug and go through the formal approval process.”
However, the official added, “There are no final details regarding the schedule as the current results are awaiting the approval for the clinical trial.”