Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Friday, 27 January 2023, 10:46 HKT/SGT
Share:
    

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.


Topic: Press release summary
Source: Eisai

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


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



Eisai
July 31, 2025 17:27 HKT/SGT
Revenue of LEQEMBI(R) (Preliminary Basis)
July 31, 2025 08:30 HKT/SGT
Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI(R) (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC
July 31, 2025 08:20 HKT/SGT
New Data Presented at AAIC Demonstrates Investigational LEQEMBI(R) (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
July 31, 2025 08:10 HKT/SGT
Two-Year Real-World Study of LEQEMBI(R) in the United States Presented at Alzheimer's Association International Conference (AAIC) 2025
July 29, 2025 08:01 HKT/SGT
LENVIMA(R) (lenvatinib) in Combination with Pembrolizumab and Transarterial Chemoembolization (TACE) Approved in China for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma
July 25, 2025 12:31 HKT/SGT
Eisai Listed for 24th Consecutive Year in FTSE4Good Index Series, an Index for Socially Responsible Investment
July 23, 2025 09:07 HKT/SGT
Launch of Beova(R) Tablets in Thailand for Overactive Bladder
July 22, 2025 10:56 HKT/SGT
Eisai To Present Four-Year Efficacy And Safety Data On Continuous Treatment With Lecanemab At The Alzheimer's Association International Conference 2025
July 16, 2025 13:50 HKT/SGT
Eisai Awarded "The 9th Bioindustry Award" for Drug Discovery Research for Anti- Amyloid B Monoclonal Antibody Lecanemab
July 14, 2025 09:20 HKT/SGT
"URECE" (Dotinurad) Launched in China as a treatment for Gout
More news >>
 News Alerts
Copyright © 2025 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | 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

Connect With us: