Skip to content
Posted on March 20, 2023 by: acn

DLT 科学基金会公开启动

Voice of Asia | Singapore

Singapore News & Headlines, Press Releases & Events

Posted on March 20, 2023 by: acn

DLT 科学基金会公开启动

  • Home
  • SEAPRWire
  • EQS Newswire
  • ACN Newswire
  • JCN Newswire
  • Contact

Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency

  • Home
  • JCN Newswire
  • Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
By: jcn Posted on January 27, 2023

TOKYO and CAMBRIDGE, Mass., Jan 27, 2023 – (JCN Newswire via SEAPRWire.com) – 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.

Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

Categories: JCN Newswire Tags: application, authorization, eisai, marketing, submitted

Post navigation

SCIB Enforces Rights to Withdraw from Project
Toyota Tsusho, IIJ, NEC, and NTT Com Sign Contract with Uzbektelecom for Telecommunications Infrastructure Development Project

Categories

  • ACN Newswire
  • EQS Newswire
  • JCN Newswire
  • SEAPRWire

Recent Stories

  • DLT 科学基金会公开启动
  • Toyota Launches the C+walk S in Japan, a New Form of Walking-Assistance Mobility
  • The DLT Science Foundation Makes its Public Launch to Revolutionize Industries and Society
  • 艾伯科技就认购杭州一芯微科技有限公司订立投资协议
  • SNS Network to Supply Apple Products and Accessories to Kumon Malaysia
  • 汽车动力电池优势巩固,国轩开拓日本储能市场有何意义
  • Another record win for Ogier aboard the GR YARIS Rally1 HYBRID
  • TOYOTA GAZOO Racing secures Sebring one-two
  • The DLT Science Foundation Makes its Public Launch to Revolutionize Industries and Society with Distributed Ledger Technology
  • 中化化肥公布2022年全年业绩 盈利同比跃增约29%
  • Liquid Hydrogen-Powered Corolla to be Absent from Round 1 of the Super Taikyu Series at Suzuka Development to Continue for Fuji 24 Hours Race
  • 中国华融发布2022年业绩预告 亏损明显收窄 夯实发展“压舱石”
  • LiveArt, Founded by Sotheby’s and Christie’s Veterans to Bring World-renowned Chinese Artists into Digital-art Space for the First Time
  • 中石化炼化工程发布2022年年度业绩 新签合同额和全年每股派息创历史新高
  • 文化传信飞龙元宇宙不断完善 打造港漫「东方英雄联盟」

Menu

  • Home
  • About Us
  • Contact Us
  • Term of Use
  • RSS Feed

Links

  • YAHOO
  • NASDAQ
  • Bloomberg
  • Newswire
  • EastMud
  • AsiaEase
  • NetDace
  • HKBrowse
  • AccessTH
  • AseanTrend
Copyright © 2023 VOASA