BIIB - Biogen files new drug application for aducanumab in Japan

Biogen (BIIB) has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare ((MHLW)) for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease. The Japanese regulatory authority will review the application through the standard review process.In addition, aducanumab is under Priority Review with the FDA, with a PDUFA action date of March 7, 2021 and is also under review with the EMA. Biogen licensed aducanumab from Neurimmune. Since October 2017 Biogen and Eisai (ESALF) have collaborated on the commercialization of aducanumab globally.

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Biogen files new drug application for aducanumab in Japan