Lee Nak-yeon (second from left), together with the Democratic Party representative, promoted the rapid development of domestic drugs from the representatives of pharmaceutical companies at a discussion meeting of the K-New Deal Committee overcoming the national crisis held on the topic of domestic development trends and prospects for Corona 19 vaccines and treatments at the National Assembly Hall in Yeouido, Seoul on the 24th of last month. I am receiving a proposal for it. From left, Jae-yong Ahn, CEO of SK Bioscience, Lee, Young-ju Kim, CEO of Jong Geun-dang, and Seung-ho Jeon, CEO of Daewoong Pharmaceutical. News 1
Chong Kun Dang’s new coronavirus infection (Corona 19) treatment,’Napaveltanju’ (ingredient name’Napamostat’) failed to pass the first gateway for product approval. The government has decided to submit additional clinical results to demonstrate the effectiveness of the treatment.
The Ministry of Food and Drug Safety announced that the decision was made by holding an external expert advisory group meeting in Napa Veltanju on the 17th at 3 pm. The advisory group said, “The results of the submitted phase 2 clinical trials alone are not sufficient to acknowledge the therapeutic effect of this drug.”
Chong Kun Dang has been conducting a clinical trial of Napabeltanju, which is commercially available as an injection for pancreatitis, as a severe treatment for Corona 19. Chong Kun Dang recently announced that 61.1% of the subjects who received Napabeltan for 10 days recovered from the results of phase 2 in Russia, showing a significantly higher effect than that of the control group (standard treatment group) (11.1%).
However, the advisory group of the Ministry of Food and Drug Safety said, “The clinical improvement time was 11 days for both the test group (52 people) and the control group (50 people), and there was no difference, so the efficacy could not be proven.” It was judged that there was no difference between the test group and the control group at 4 days, too.
The advisory group also said, “In order to prove the clinical improvement effect in the patient group, a clinical trial should be performed according to a predefined hypothesis and a statistical test should be performed. It was a judgment that it was appropriate to use exploration.” In addition, he added, “It was also considered that the design of the clinical trial was an’open’ trial, and the objectivity and reliability of the clinical trial were limited.”
According to the results of this meeting, the Ministry of Food and Drug Safety will not hold a meeting of the Central Pharmacist Review Committee, the next step in the triple consultation procedure for COVID-19 treatment and vaccine. In the future, it plans to support the faithful design and progress of a phase 3 clinical trial plan in Napa Veltan.
Previously, the Ministry of Food and Drug Safety was the first in Korea to market Celltrion’s antibody treatment’Rekironaju’.
An official from Chong Kun Dang of this result said, “The efficacy has been proven for some high-risk patients, but the Ministry of Food and Drug Safety judges that it is insufficient.”
Yu Hwan-gu reporter [email protected]
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