Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Tuesday, 22 March 2016, 14:35 HKT/SGT

Source: Eisai
Eisai Withdraws New Drugs Application for Mecobalamin Ultra-High Dose Preparation as Treatment for Amyotrophic Lateral Sclerosis

TOKYO, Mar 22, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has withdrawn its new drug application for ultra-high dose Mecobalamin development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.

On May 27, 2015, Eisai submitted a new drug application for mecobalamin seeking approval as a treatment for ALS. As a result of meetings with the Pharmaceuticals and Medical Devices Agency (PMDA), the application package submitted was not sufficient for approval, and therefore Eisai has withdrawn the application. Eisai will carefully reconsider the future development strategy for mecobalamin after
consultation with the regulatory authority.

ALS is an intractable, progressive, neurodegenerative disease that causes severe muscle atrophy and weakness in the muscles. With treatment options currently limited, this is a disease with significant unmet medical need. Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs in neurology and further contribute to increasing the benefit for patients and their families.

Public Relations Department,
Eisai Co., Ltd.

Topic: Press release summary
Source: Eisai

Sectors: BioTech
From the Asia Corporate News Network

Copyright © 2021 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

Nov 30, 2021 09:13 HKT/SGT
Eisai and FCNT Enter Into Business Alliance Aiming to Support People Living with Dementia and to Prevent Dementia
Nov 30, 2021 08:56 HKT/SGT
Eisai to Present Latest Data on Perampanel and E2730 at the 75th American Epilepsy Society Annual Meeting
Nov 29, 2021 11:44 HKT/SGT
European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma
Nov 29, 2021 09:15 HKT/SGT
European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma
Nov 18, 2021 14:28 HKT/SGT
Eisai Receives the 'Most Liked!' IR Award at The 2021 IR Award
Nov 12, 2021 15:10 HKT/SGT
Eisai: New Phase 3 Data Show Positive Correlation Between ADUHELM Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer's Disease
Nov 12, 2021 14:31 HKT/SGT
Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer's Disease (CTAD) Conference
Nov 12, 2021 14:03 HKT/SGT
Eisai: Introduction of Plasma-based Biomarker Screening to Facilitate Identification of Subjects for Phase 3 Ahead 3-45 Trial Presented at Clinical Trials on Alzheimer's Disease (CTAD) Conference
Nov 11, 2021 11:05 HKT/SGT
Eisai Presents Late-Breaker Updates on Lecanemab Clinical, Biomarker and Safety Data from Phase 2b Study Core and Open-Label Extension
Nov 9, 2021 09:46 HKT/SGT
Eisai: DIAN-TU Selects Lecanemab as Background Anti-Amyloid Therapy in Clinical Trial Evaluating Investigational Therapy Targeting Tau for Dominantly Inherited Alzheimer's Disease
More news >>
 News Alerts
Copyright © 2021 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 | Beijing: +86 400 879 3881 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575

Connect With us: