Verification advisory group recommends review by submitting clinical results that can confirm treatment effect
The Ministry of Food and Drug Safety (Director Kang-rip Kim) decided to submit and review the results of Phase 3 clinical data on Chong Kun Dang’s COVID-19 treatment Napaveltanju.
The Ministry of Food and Drug Safety held a meeting of the verification advisory group today (17th) and reviewed the safety and effectiveness of Napaveltanju.
The meeting was attended by five people, including infectious medicine specialists and clinical statistics experts, as well as four people, including the general review team and clinical review team of the chemotherapeutic agent review team of the Ministry of Food and Drug Safety’s Internal Corona 19 Crisis Response Support Headquarters.
According to the submitted data, the clinical improvement time, which is the main evaluation index for efficacy, was 11 days in both the test group and the control group, and the efficacy was not proven.
The time for the virus test result to change from positive to negative (the time required for virus negative prevalence) was also 4 days in both the test group and the control group.
However, as a result of an additional analysis of some specific patient groups with an early warning score of 7 or more, the clinical improvement time showed a difference of 11 days for the test group and 14 days for the control group.
In terms of safety, there were no unexpected adverse reactions, such as phlebitis, hyponatremia, and respiratory failure, which frequently appeared in the test group.
The verification advisory group said that the results of the phase 2 clinical trials submitted alone are not sufficient to admit the therapeutic effect due to the fact that the objective and reliability of the clinical trials are poor due to the design of the clinical trial as an open trial, and the efficacy with the control group has not been proven. It was judged that additional clinical trials that can confirm the treatment effect are necessary for’adding efficacy and effect on the treatment of Corona 19.’
Therefore, it is not appropriate to approve only the results of the submitted phase 2 clinical trial, and it is recommended that additional clinical results that can confirm the treatment effect be submitted and reviewed for approval.
The Ministry of Food and Drug Safety announced that it will not hold a meeting of the Central Pharmacy Review Committee, the next step in the triple consultation procedure for COVID-19 treatment and vaccine, according to the results of this verification advisory group meeting.
He added that it plans to support the faithful design and progress of a phase 3 clinical trial plan in Napaveltan.
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