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 ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma
October 30 2025 13:43 JST
 
Merck & Co., Inc. and Eisai Announce WELIREG(R) (belzutifan) Plus LENVIMA(R) (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
October 28 2025 23:30 JST
 
Health Canada Grants Authorization for "LEQEMBI(R)" (lecanemab) for the Treatment of Early Alzheimer's Disease
October 27 2025 13:23 JST
 
LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025"
October 14 2025 16:54 JST
 
Eisai and Biogen Announce U.S. Availability of LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease
October 08 2025 11:03 JST
 
Eisai Highlights Breadth of Oncology Research at ESMO 2025
October 03 2025 17:01 JST
 
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China
September 29 2025 09:33 JST
 
LEQEMBI(R) (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Australia
September 24 2025 18:04 JST
 
Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
September 17 2025 17:20 JST
 
"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
September 12 2025 12:20 JST
 
More Press release >>

Latest Press Release


More Latest Release >>