Biogen applies for approval of Alzheimer’s drug, aducanumab in Japan

Biogen said it has filed for regulatory approval in Japan for an Alzheimer’s disease drug it developed with local partner Eisai.

The drug aducanumab is also under regulatory review in the United States and Europe. Biogen and Eisai have jointly developed three experimental drugs for Alzheimer’s, which affects millions around the world and has not seen a new treatment in decades.

Biogen in October 2019 revived approval plans for aducanumab months after an analysis of its two pivotal trials showed the drug was unlikely to succeed.

Last month, an outside panel of advisers to the US Food and Drug administration said the drug had not been proven to slow progression of the disease. The FDA could still decide to approve the drug.