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The Ministry of Food and Drug Safety announced on the 17th that it was inappropriate to approve this drug on the grounds that Napabeltan has not proven its effectiveness as a corona treatment. Previously, after conducting phase 2 clinical trials on 104 severely coronavirus patients in Russia, on the 8th, he applied for conditional approval for corona treatment with the Ministry of Food and Drug Safety.
◇ Announcement without the result of the main evaluation index
This misappropriation of permission goes beyond regret and spreads into controversy over moral hazard. This is because Chong Kun Dang announced only the treatment results of the high-risk group without mentioning the results of major evaluation indicators in the clinical results announcement in January.
In January, Chong Kun Dang announced in a press release entitled’Napa Beltan Corona 19 Treatment Effect Confirmation’ that “the treatment effect was about 2.9 times higher than that of the standard treatment group in patients with high risk of Corona 19.”
However, the Ministry of Food and Drug Safety evaluated Napabeltan in the opposite direction. The Ministry of Food and Drug Safety pointed out that the clinical improvement time, which is the main evaluation index, was 11 days in both the test group (52 patients) and the control group (50 patients), indicating that the efficacy could not be proven. In addition, he added that there was no difference in the time for the virus test result to change from positive to negative at 4 days in both the test and control groups. This was not mentioned in the previous Chong Kun Dang presentation.
The pharmaceutical industry, which received the results of the main clinical evaluation index of Nipabeltan, criticized Chong Kun Dang strongly. An official in the pharmaceutical industry said, “There is no difference between patients who have injected napaveltan and took Napabeltan for 10 days, and those who did not have a 24-hour injection needle in terms of clinical results of 104 people. I raised my voice. During the clinical period, napabeltan was administered to the test group, and only basic treatments such as oxygen therapy and antipyretic drugs were performed in the control group.
In response to this controversy, an official from Chong Kun Dang admitted that “the total of 104 clinical patients could not find any significant statistical difference between the treatment group and the placebo group.” It’s just that,” he explained.
◇ Due to the corona 19 pandemic, a hurry to apply for permission was left unreasonable.
The arrow of criticism is also heading toward the head of Chong Kun Dang, who has an irrational number of applying for conditional approval despite the lack of Napa Beltan’s major clinical evaluation indicators. An expert in the pharmaceutical and bio industry said, “In clinical practice, if the major evaluation indicators are not met, it is considered a clinical failure.” And pinched.
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A high-ranking pharmaceutical company official said, “The probability of success of innovative new drugs is only 1 in 10,000 and drug re-creation is only 1 in 1,000. He pointed out that the permit process should have been carried out.”
It is said that officials from the Ministry of Food and Drug Safety, who are in charge of the actual permits, were also quite confused after confirming the results of the first and second evaluation indicators of Napa Beltan. Chong Kun Dang’s side said, “In a pandemic situation, I applied for conditional permission to release a treatment as soon as possible,” and said, “I didn’t think the permission would be disapproved because there was little data for high risk groups.” Chong Kun Dang said that the management who received the clinical data of Napa Beltan from Russia decided to apply for conditional approval to the Ministry of Food and Drug Safety after a meeting.
◇ Clinical Phase 3, Chong Kun Dang “Successful Self” vs. Pharmaceutical Industry “Sleep 3 Phase”
As the situation becomes like this, prospects are mixed even over the phase 3 clinical trial of Napa Beltan. Chong Kun Dang applied for approval of Phase 3 clinical trial of Napabetan to the Ministry of Food and Drug Safety on the 8th. An official in the pharmaceutical industry diagnosed, “The 2nd phase of clinical trials failed, what will the 3rd phase mean?”
On the other hand, Chong Kun Dang is confident of demonstrating the effectiveness of Napa Beltan’s corona treatment through phase 3 clinical trials. An official from Chong Kun Dang said, “In the phase 2 clinical trial of Napabeltan, significant results were obtained for severe patients in the high-risk group.” I said.
The Ministry of Food and Drug Safety said that Chong Kun Dang’s emphasis on the treatment effect of severe patients in high-risk groups was not reflected in the approval review, citing that it was a result outside the clinical design. He said, “The problem was that Napa Beltan was not effective in phase 2 clinical trials, but that the results did not come out according to the clinical design. “I asked. The Ministry of Food and Drug Safety announced the day before that it plans to support Napa Beltan’s phase 3 clinical trial plan to be faithfully designed and carried out.