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  • Biogen¡¯s Alzheimer¡¯s disease TX entry unclear in Korea
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Aug 4, 2022 06:05am
unable to pass Central Pharmaceutical Affairs Council
Expert council disapproves clinical trial results
Introduction of the world¡¯s first Alzheimer¡¯s disease treatment, ¡®Aduhelm (aducanumab),¡¯ has virtually become unclear in Korea.

The results of the Central Pharmaceutical Affairs Council meeting that was held on July 12th that was recently disclosed by the Ministry of Food and Drug Safety showed that the expert advisory board concluded that the application data filed for an Alzheimer¡¯s disease treatment "was not sufficient to be accepted as a confirmatory clinical trial."

Although the deliberated product's name and ingredient were not disclosed in the minutes of the meeting, one committee member mentioned, ¡°Since the FDA approval, the US news had covered how the ¡®Biogen's statisticians used magic' to bec
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