TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Jun 24, 2021 12:00 JST
Source:
Eisai
Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)
An Anti-amyloid Beta Protofibril Antibody for The Treatment Of Alzheimer's Disease
TOKYO, Jun 24, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer's disease (AD).
Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Abeta) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.
In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the the Phase 3 Clarity AD study. The study's primary endpoint is expected to be completed by the end of September 2022. Additionally, the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Study 201 confirmed time-dependent reduction of brain Abeta in individuals newly treated with lecanemab and was presented at the 2021 Alzheimer's Disease and Parkinson's Disease Conference.
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 any investigational uses of such product will successfully complete clinical development or gain health authority approval.
For more information, visit:
https://www.eisai.com/news/2021/news202151.html
.
Source: Eisai
Sectors: BioTech
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)
April 18 2024 09:53 JST
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan
April 17 2024 15:17 JST
French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics
April 03 2024 15:24 JST
Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA
April 01 2024 08:39 JST
Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical
March 29 2024 14:51 JST
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture
March 29 2024 14:19 JST
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024
March 29 2024 13:32 JST
Lifenet and Eisai Co-Develop Dementia Insurance "be"
March 21 2024 16:36 JST
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace
March 21 2024 15:10 JST
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients
March 06 2024 16:47 JST
More Press release >>
Latest Press Release
Mazda Production and Sales Results for March 2024 and for April 2023 through March 2024
Apr 25, 2024 18:21 JST
MHI Begins Operation of SOEC Test Module the Next-Generation High-Efficiency Hydrogen Production Technology at Takasago Hydrogen Park
Apr 25, 2024 17:45 JST
GAC Honda to Begin Sales of All-new e:NP2, the Second Model of e:N Series
Apr 25, 2024 16:50 JST
Toyota Exhibiting at Beijing Motor Show 2024
Apr 25, 2024 16:25 JST
Honda Reaches Basic Agreement with Asahi Kasei on Collaboration for Production of Battery Separators for Automotive Batteries in Canada
Apr 25, 2024 11:10 JST
UNIQLO Sponsors KAWS + Warhol Exhibition Tour, Starting in Pittsburgh
Apr 25, 2024 09:00 JST
Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date
Apr 24, 2024 17:19 JST
MC and Denka Sign J/V Agreement in Fullerene Business
Apr 24, 2024 17:02 JST
Mitsubishi Motors Posts Record Sales in the Philippines in FY2023
Apr 24, 2024 13:56 JST
NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance
Apr 24, 2024 13:25 JST
Fujitsu SX Survey reveals key success factors for sustainability
Apr 23, 2024 10:25 JST
Fujitsu and METRON collaborate to drive ESG success: slashing energy costs, boosting productivity with new manufacturing industry solutions
Apr 22, 2024 16:09 JST
NEC Strengthens Commitment to Space Industry with Investment in Seraphim Space Venture Fund II
Apr 22, 2024 15:09 JST
Soft Space Launches the First and Only JCB Payment Gateway in Malaysia
Apr 22, 2024 15:00 JST
TOYOTA GAZOO Racing takes a one-two in Croatian thriller
Apr 22, 2024 10:47 JST
First-ever Mazda CX-80 Crossover SUV Unveiled in Europe
Apr 19, 2024 13:50 JST
Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces
Apr 19, 2024 10:17 JST
Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas
Apr 18, 2024 17:01 JST
Toyota Launches All-New Land Cruiser "250" Series in Japan
Apr 18, 2024 13:39 JST
Fujitsu and Oracle collaborate to deliver sovereign cloud and AI capabilities in Japan
Apr 18, 2024 11:14 JST
More Latest Release >>