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 (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has withdrawn its new drug application for ultra-high dose Mecobalamin development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.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Devices Agency (PMDA), the application package submitted was not sufficient for approval, and therefore Eisai has withdrawn the application.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.
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visitwww.eisai.com.
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
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