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

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 (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has withdrawn its new drug application for ultra-high dose Mecobalamin development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.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Devices Agency (PMDA), the application package submitted was not sufficient for approval, and therefore Eisai has withdrawn the application.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.


Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120


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
Sept 8, 2025 16:49 HKT/SGT
Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025
Sept 4, 2025 09:56 HKT/SGT
Eisai to Present Latest Data on Lemborexant and Novel Orexin Receptor Agonist E2086 at The World Sleep 2025
Sept 3, 2025 10:32 HKT/SGT
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
Sept 1, 2025 12:44 HKT/SGT
FDA Approves LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Aug 29, 2025 17:17 HKT/SGT
Ministry Of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma
Aug 25, 2025 18:30 HKT/SGT
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI(R) (lecanemab)
Aug 18, 2025 08:11 HKT/SGT
Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R) (Lemborexant) in China
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
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: