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 ©2021 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090
February 22 2021 14:40 JST
 
Eisai Receives Corporate Philanthropy Award for Its Efforts to Realize Human Health Care (hhc) Philosophy
February 22 2021 12:11 JST
 
LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
February 15 2021 10:07 JST
 
Eisai to Launch Parkinson's Disease Treatment Equfina in South Korea
February 01 2021 08:35 JST
 
Eisai Listed as a Global 100 Most Sustainable Corporation for the Fifth Time
January 26 2021 10:58 JST
 
Eisai to Present Abstracts on Lenvatinib at 2021 Gastrointestinal Cancers Symposium
January 12 2021 11:37 JST
 
Eisai Completes Construction of the 5th Manufacturing Building at Kawashima Industrial Park in Japan
December 18 2020 12:09 JST
 
LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination Demonstrated Statistically Significant Improvement in OS, PFS and ORR
December 17 2020 11:47 JST
 
Eisai to Present Abstracts on Oncology Products and Pipeline at 43rd Annual San Antonio Breast Cancer Symposium
December 04 2020 11:17 JST
 
Eisai to Present Latest Data on Perampanel at the 74th American Epilepsy Society Annual Meeting
November 30 2020 13:04 JST
 
More Press release >>

Latest Press Release


More Latest Release >>