TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Jan 27, 2023 11:46 JST
Source:
Eisai
Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease Accepted by European Medicines Agency
TOKYO and CAMBRIDGE, Mass., Jan 27, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline.
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 based on the results from the Phase III Clarity AD confirmatory study. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. In China, Eisai has initiated submission of data for a 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.
*Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.(1),(2)
(1) "Lecanemab Sweeps up Toxic AΒ Protofibrils, Catches Eyes of Trialists." ALZFORUM, ALZFORUM, 21 Nov. 2021, bit.ly/3HzXXyE.
(2) Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2): e32014. doi: 10.1371/journal.pone.0032014. Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.
For more information, visit www.eisai.com/news/2023/news202311.html.
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI(R) (lecanemab-irmb) Maintenance Treatment in Early Alzheimer's Disease at CTAD 2025
December 04 2025 17:36 JST
New Data Presented at CTAD 2025 Confirms Pharmacological Effect of LEQEMBI(R) (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CSF
December 03 2025 17:19 JST
Eisai Presents New Data on Anti-Tau Antibody Etalanetug (E2814) at CTAD 2025
December 02 2025 23:01 JST
Eisai Submits New Drug Application for Subcutaneous Formulation of "LEQEMBI(R)" for the Treatment of Early Alzheimer's Disease in Japan
November 28 2025 22:00 JST
Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) IQLIK(TM) (lecanemabirmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
November 26 2025 18:42 JST
"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
More Press release >>
Latest Press Release
Lexus World Premieres Lexus LFA Concept BEV Sports Car
Dec 05, 2025 19:13 JST
TOYOTA GAZOO Racing World Premieres GR GT & GR GT3
Dec 05, 2025 18:58 JST
TOYOTA GAZOO Racing and Lexus Hold World Premiere of GR GT, GR GT3, and Lexus LFA Concept
Dec 05, 2025 18:24 JST
World's First General Design Approval (GDA) for Developed Steel and Post-Weld Heat Treatment (PWHT) Exemption based on ECA for Low-pressure Liquefied CO2 Tank made of KF460 steel
Dec 05, 2025 18:17 JST
Hitachi at CES 2026: Building a Harmonized Society Through Technology
Dec 04, 2025 19:40 JST
Fujitsu and Scaleway partner to accelerate European sustainable transformation and data sovereignty with FUJITSU-MONAKA CPU-based AI inference
Dec 04, 2025 19:08 JST
NEC Orchestrating Future Fund Invests in PopID, Inc. to Accelerate Global Expansion of Biometric Payment Solutions and Launch a Strategic Collaboration
Dec 04, 2025 18:52 JST
Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI(R) (lecanemab-irmb) Maintenance Treatment in Early Alzheimer's Disease at CTAD 2025
Dec 04, 2025 18:36 JST
The 26th Hong Kong Forum marks successful completion
Dec 03, 2025 22:44 JST
New Data Presented at CTAD 2025 Confirms Pharmacological Effect of LEQEMBI(R) (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CSF
Dec 03, 2025 18:19 JST
Mitsubishi Motors Launches the All-New Destinator in Vietnam
Dec 03, 2025 18:00 JST
Anime Tokyo Station: Celebrating the 25th Anniversaries of Two Popular Anime with an Anniversary Joint Exhibition Starting November 15
Dec 03, 2025 11:30 JST
Eisai Presents New Data on Anti-Tau Antibody Etalanetug (E2814) at CTAD 2025
Dec 03, 2025 00:01 JST
NEC Launches AI Agent Service in Japan to Automate Procurement Negotiations Using AI
Dec 02, 2025 23:43 JST
Fujitsu develops new technology to support human-robot collaboration
Dec 02, 2025 23:26 JST
Fujitsu establishes international consortium to tackle disinformation/misinformation and new AI risks
Dec 02, 2025 22:55 JST
Fujitsu achieves high-precision, long-duration molecular dynamics simulation for all-solid-state battery interphases with over 100,000 atoms
Dec 01, 2025 23:04 JST
Fujitsu develops multi-AI agent collaboration technology to optimize supply chains, launches joint trials
Dec 01, 2025 22:43 JST
Fujitsu launches 'Fujitsu Accelerator Program for SPORTS' to create new value through Sports x Technology
Dec 01, 2025 22:14 JST
Eisai Submits New Drug Application for Subcutaneous Formulation of "LEQEMBI(R)" for the Treatment of Early Alzheimer's Disease in Japan
Nov 28, 2025 23:00 JST
More Latest Release >>