TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Dec 11, 2020 10:43 JST
Source:
Eisai
Eisai: Biogen Files New Drug Application for Aducanumab in Japan
- If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer's disease
- Aducanumab is now under regulatory review in Japan, Europe and the United States
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 global leadership in setting policies that aim to increase support for Alzheimer's disease patients and caregivers. We look forward to the regulatory review of aducanumab with the hope that, if approved, it could help further manage the impact of this devastating disease."
"As Japan has the oldest population in the world, it is anticipated that the social burden of Alzheimer's disease will continue to grow," said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "For more than 30 years, Eisai has been dedicated to dementia research and development, and working with people living with Alzheimer's and their caregivers to fight this disease. The filing of the application is an important step in serving patients and their families as aducanumab may help reduce clinical decline and potentially maintain the ability to live an independent life for as long as possible. Aducanumab also has the potential to help address the public health challenges our aging population faces in Japan."
The Japanese regulatory authority will review the application through the standard review process. In addition to the filing in Japan, aducanumab is under Priority Review with the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021 and is also under review with the European Medicines Agency.
Source: Eisai
Sectors: Healthcare & Pharm
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom
November 17 2025 21:08 JST
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
More Press release >>
Latest Press Release
Special Autumn Event: "Anime Tokyo Station Autumn Festival"
Nov 20, 2025 13:00 JST
ANIME TOKYO STATION ON ROBLOX: New Game "ANIME SKILL TCG" Out Now!
Nov 20, 2025 11:00 JST
DENSO and DELPHY Sign Joint Development Agreement to Accelerate Data-Driven Smart Horticulture
Nov 19, 2025 23:41 JST
NEC Presents the Decarbonization Potential of its CropScope Agricultural Solution at COP30
Nov 19, 2025 23:15 JST
Fujitsu recognized as the only Japan-headquartered company to be an Emerging Leader in Gartner(R) Emerging Market Quadrant for Generative AI Engineering
Nov 19, 2025 22:40 JST
Kingsoft Announces 2025 Third Quarter Results
Nov 19, 2025 17:47 JST
Mazda Begins Demonstration Experiment of Onboard CO2 Capture System
Nov 18, 2025 00:38 JST
Pushing Hydrogen Engine Technology to New Heights in the Super Taikyu Series Final Race
Nov 18, 2025 00:00 JST
Fujitsu launches business creation lab in collaboration with AWS Japan
Nov 17, 2025 23:41 JST
NTT DOCOMO Achieves Successful Outdoor Trial of AI-Driven Wireless Interface Toward 6G
Nov 17, 2025 23:05 JST
Destinator Earns the Highest Rating of Five Stars in 2025 ASEAN NCAP
Nov 17, 2025 22:32 JST
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom
Nov 17, 2025 22:08 JST
NEC Advances Research Information Infrastructure for Open Science
Nov 17, 2025 21:38 JST
Mitsubishi Shipbuilding Delivers Large Car Ferry KEYAKI to Shin Nihonkai Ferry and Japan Railway Construction, Transport and Technology Agency
Nov 17, 2025 21:00 JST
Hitachi Employee Receives the "Chop Wood Carry Water Award" from the Global OSS Organization CNCF for Leading the Establishment of Official Community in Japan
Nov 14, 2025 21:06 JST
The University of Osaka D3 Center and NEC Demonstrate Wide-Area Distributed Campus AI Processing Platform
Nov 14, 2025 00:41 JST
Toyota to Invest Up to $10 Billion Additional in Its U.S. Operations Over the Next Five Years
Nov 14, 2025 00:08 JST
MHI Thermal Systems Launches Magnetic Bearing Centrifugal Chiller "ETI-N" Series for Japanese Market
Nov 13, 2025 23:34 JST
MHI Completes Joint Demonstration with Kirin Group for Automation of Warehouse Operations, and Truck Loading and Unloading
Nov 13, 2025 23:00 JST
JCB launches second round of Shopping Mall Shuttle Free Ride Campaign in Guam
Nov 13, 2025 11:00 JST
More Latest Release >>