English | 简体中文 | 繁體中文 | 한국어 | 日本語
Wednesday, 6 July 2022, 10:12 JST
Share:
    

Source: Eisai
U.S. FDA Accepts and Grants Priority Review for Eisai's Biologics License Application of Lecanemab
For Early Alzheimer's Disease Under the Accelerated Approval Pathway

TOKYO, July 6, 2022 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Eisai's application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.

"Alzheimer's disease is a serious disease that causes significant disability and burden to the people living with Alzheimer's disease and their families. Treatment options for Alzheimer's disease are limited and creation of new treatment options is strongly encouraged. Eisai employees have spent time with people living with Alzheimer's disease to truly understand their feelings and challenges and have been working to create new treatments for many years," said Haruo Naito, Chief Executive Officer at Eisai. "The acceptance of lecanemab's BLA with priority review is an important milestone in serving people living with Alzheimer's disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer's disease. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with Alzheimer's disease and their families as soon as possible."

"We believe in a future where people living with Alzheimer's disease will have different treatment options to address this complex disease, and today's BLA acceptance with priority review by FDA is an important step towards this vision," said Michel Vounatsos, Chief Executive Officer at Biogen. "Together with Eisai, we are committed to continuing our work to address the tremendous unmet need for these patients and their families."

The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab in order to expedite patients' access to lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai will submit for traditional approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends on March 31, 2023.

In Japan, in March 2022, Eisai initiated the submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab. Eisai aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

For more information, visit www.eisai.com/news/2022/pdf/enews202254pdf.pdf.

Topic: Press release summary
Source: Eisai

Sectors: BioTech
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Eisai Related News
Friday, 25 July 2025, 13:31 JST
Eisai Listed for 24th Consecutive Year in FTSE4Good Index Series, an Index for Socially Responsible Investment
Wednesday, 23 July 2025, 10:07 JST
Launch of Beova(R) Tablets in Thailand for Overactive Bladder
Tuesday, 22 July 2025, 11:56 JST
Eisai To Present Four-Year Efficacy And Safety Data On Continuous Treatment With Lecanemab At The Alzheimer's Association International Conference 2025
2025年7月16日 14時40分 JST
エーザイ、抗アミロイドβ抗体レカネマブの創薬研究が「第 9 回バイオインダストリー大賞」を受賞
Wednesday, 16 July 2025, 14:50 JST
Eisai Awarded "The 9th Bioindustry Award" for Drug Discovery Research for Anti- Amyloid B Monoclonal Antibody Lecanemab
More news >>
Copyright © 2025 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575