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Eisai: Biogen Files New Drug Application for Aducanumab in Japan JCN Newswire 2020-12-11 TOKYO, Dec 11, 2020 - (JCN Newswire) - Biogen and Eisai, Co., Ltd. (Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer s disease. Aducanumab, 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 (MCI) due to Alzheimer s disease and mild Alzheimer s disease dementia. Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world, said Michel Vounatsos, Chief Executive Officer at Biogen. Japan has met the challenges of a rapidly-aging population by demonstrating globa

Haruo naitoMichel vounatsosCo ltdEisai co ltdEuropean medicines agencyMinistry of healthDrug administrationBiogen files new drug applicationJapanese new drug applicationMild cognitive impairmentChief executive officerPriority reviewPrescription drug user fee actEuropean medicinesஇணை லிமிடெட்ேசை இணை லிமிடெட்