Biogen: Japan's NDC Seeks Additional Data On Application For Approval Of Aducanumab

(RTTNews) - Biogen Inc. (BIIB) and Eisai Co. Ltd. said the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council 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 the process.

As of October 2017, Biogen and Eisai are collaborating on the global co-development and co-promotion of aducanumab. The companies said they will continue to actively engage with the Pharmaceuticals and Medical Devices Agency in Japan to agree on additional data requirements.