TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Jan 16, 2023 18:56 JST
Source:
Eisai
Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan
TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).
This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.
In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.
In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).
In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 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.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.
For more information, visit www.eisai.com/news/2023/news202307.html.
MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120
Eisai Inc. (U.S.)
Libby Holman
+ 1-201-753-1945
Libby_Holman@eisai.com
INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
TEL: +81-(0)03-3817-5122
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
More Press release >>
Latest Press Release
DENSO Acquires Axia Vegetable Seeds to Realize Sustainable Agriculture
Jul 04, 2025 16:20 JST
MHIET Launches 450kW Gas Cogeneration System Capable of Hydrogen Co-Firing
Jul 04, 2025 15:13 JST
Yachiyo Engineering and NEC launch adaptation finance study in Indonesia to calculate the adaptation value of disaster prevention measures
Jul 04, 2025 13:25 JST
Fujitsu to implement store monitoring solution for METRO Inc. in Canada, enhancing operational efficiency and policy compliance
Jul 04, 2025 13:19 JST
Fujitsu to develop ETF trading platform based on TSE's CONNEQTOR and provide it to Australian Securities Exchange
Jul 03, 2025 11:14 JST
Mitsubishi Motors Launches the All-New Grandis for the European Market
Jul 02, 2025 12:10 JST
Valuufy partners with Mainichi Future Creation Lab, Supporting New Approaches to Business Sustainability
Jul 02, 2025 12:00 JST
Fujitsu launches solution to enhance customers' global supply chain resilience
Jul 02, 2025 11:32 JST
MHI Receives Order to Supply Four Circulating Water Pumps for Units 5 and 6 of Sanmen Nuclear Power Plant in China Under Collaboration with Dongfang Electric Machinery
Jul 02, 2025 11:30 JST
Multi-purpose Arena in Odaiba Aomi Area TOYOTA ARENA TOKYO Construction Completed
Jul 01, 2025 22:56 JST
1Finity, a Fujitsu company, commences operations and reveals brand identity
Jul 01, 2025 22:53 JST
MHI Thermal Systems Begins Field Test of Jointly Developed "Surplus Renewable Energy Absorption and Release System"
Jul 01, 2025 22:40 JST
Japan's Telecommunications Carriers Strengthen Disaster Response Through Collaborative Information Sharing
Jul 01, 2025 22:30 JST
JCB and Mandai Wildlife Group Deepen Partnership with exclusive discounts for JCB cardmembers
Jul 01, 2025 16:00 JST
Fujitsu provides Japan's first AI-powered cloud-based library search service
Jul 01, 2025 11:30 JST
JCB Brings Apple Pay to Cardmembers in Vietnam
Jul 01, 2025 11:15 JST
First Shipment of LNG from the LNG Canada Project
Jul 01, 2025 11:00 JST
Approval in Principle (AiP) for World's First LCO2 / Methanol Carrier
Jun 30, 2025 20:30 JST
Acropolis Rally Greece: Day 4 Sunday success and second overall for TOYOTA GAZOO Racing's Ogier
Jun 30, 2025 20:15 JST
Mitsubishi Fuso-Hino Merger: 4 Firms Collaborate for the Future of Commercial Vehicles
Jun 30, 2025 20:10 JST
More Latest Release >>