Biogen and Eisai file for Japan approval of Aducanumab

Just crossed the news wires (see below). I am almost certain this will get approved in Japan. Things work differently there and there is no way in my view that Eisai would have allowed this to be put forward if they had not had some understanding with the regulator. Also Japan has been very explicit about being accommodating to drugs and therapies that target issues with an aging population.

Biogen (BIIB) said it has submitted a new drug application for aducanumab, an investigational therapy for Alzheimer's disease, in Japan.The company said the Japanese regulatory authority will review the application through the standard review process. In addition, aducanumab is under Priority Review with the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act or PDUFA action date of March 7, 2021 and is also under review with the European Medicines Agency.Aducanumab or BIIB037, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., Ltd. have collaborated on the development and commercialization of aducanumab globally.Alzheimer's disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death.