Apr 23, 2021 09:07 JST

Source: Eisai

Notice Regarding Biogen's Disclosure About the Submission of Marketing Authorization Applications in Brazil, Canada, Australia, and Switzerland for Aducanumab for Alzheimer's Disease

TOKYO, Apr 23, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that Biogen (Nasdaq: BIIB) has disclosed, in its Q1 2021 Earnings Press Release issued on April 22, its current submission status of the Marketing Authorization Applications (MAA) for aducanumab, an investigational treatment for Alzheimer's disease, in countries other than the United States, Japan, and in Europe which have been announced previously.

In the first quarter of 2021 Biogen submitted a MAA to Ag?ncia Nacional de Vigil?ncia Sanit?ria (ANVISA) in Brazil for aducanumab an investigational treatment for Alzheimer's disease. This application is currently in queue for review.

Biogen also submitted MAAs for aducanumab to Health Canada, the Therapeutic Goods Agency in Australia, and Swissmedic in Switzerland, all of which are subject to agency validation of whether the applications are accepted.

Aducanumab is being jointly developed by Biogen and Eisai.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

Source: Eisai
Sectors: BioTech

Copyright ©2026 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Pfizer and Eisai Commence Co-promotion of "NURTEC(R)" for the Acute Treatment and Prophylaxis (Preventive Treatment) of Migraine
July 27 2026 22:50 JST
 
Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by European Medicines Agency (EMA)
July 17 2026 23:24 JST
 
LEQEMBI(R) Real-World LEADER Study Presented at AAIC(R) 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of Treatment
July 15 2026 23:18 JST
 
FDA Approves LEQEMBI IQLIK(R) (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer's Disease
July 15 2026 22:51 JST
 
Eisai Presents Latest Findings Showed Etalanetug Reduced Alzheimer's Disease Tau Tangle-Specific Plasma Biomarker MTBR-tau243 at Alzheimer's Association International Conference(R) (AAIC(R)) 2026
July 15 2026 22:21 JST
 
LEQEMBI(R) Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference(R) (AAIC(R)) 2026
July 13 2026 23:06 JST
 
Eisai to Showcase Alzheimer's Disease Portfolio with More Than 50 Presentations at the Alzheimer's Association International Conference(R) 2026 (AAIC(R))
July 02 2026 21:45 JST
 
UCL and Eisai renew partnership to accelerate treatments for neurodegenerative diseases
July 02 2026 21:01 JST
 
Eisai Announces Strategic Investment Supported by the UK Government's LSIMF
June 17 2026 12:28 JST
 
Eisai Deepens Body of Clinical Evidence for LENVIMA(R) (Lenvatinib) Across Established Indications at ASCO 2026
May 21 2026 23:23 JST
 
More Press release >>

Latest Press Release


More Latest Release >>