Posted by Michael Wonder on 26 Dec 2021
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review
22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare in Japan has decided to continue deliberations on the application for the manufacturing and marketing approval of aducanumab for the treatment of Alzheimer’s disease.
The First Committee on New Drugs is seeking additional data to be submitted as part of this process.
The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency in Japan to agree on additional data requirements.
