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Wednesday, 27 May 2015, 15:15 HKT/SGT
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Source: Eisai
Eisai Submits New Drug Application for Mecobalamin Ultra-High Dose Preparation as Treatment for Amyotrophic Lateral Sclerosis in Japan

TOKYO, May 27, 2015 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a new drug application for mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.

ALS is an intractable, progressive, neurodegenerative disease that causes severe muscle atrophy and weakness in the muscles. Since there is only one medicine approved for suppressing the progression of ALS in Japan, there is a significant unmet medical need for new treatment options.

Mecobalamin is approved and marketed as a treatment for peripheral neuropathies and other conditions. Since the 1990s, clinical research has been carried out on the effect of ultra-high dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare's Specified Disease Treatment Research Program. The results of this research suggested efficacy for ultra-high dose mecobalamin in ALS. In light of these findings, Eisai began clinical trials on ultra-high dose mecobalamin in 2004 and a Phase II/III clinical study (Study 761) was initiated in 2006. Study 761 was conducted as a double-blind, placebo-controlled study with the primary endpoints being time to event (use of ventilation, or death) and change in total score of the Japanese version of the ALS Functional Rating Scale-Revised (ALSFRS-R).

Although the results of Study 761 showed a trend for mecobalamin (both 25 mg and 50 mg groups) of a longer time to event and a trend in slowing the decline in ALSFRS-R scores when compared to placebo, a statistically significant difference could not be confirmed. On the other hand, the results of an additional analysis showed that ultra-high dose mecobalamin extends time to event and slows decline in ALSFRS-R scores in patients who commenced treatment within 12 months of ALS onset. Furthermore, ultra-high dose mecobalamin demonstrated a similar effect in patients with lower serum lipid levels. Meanwhile, the incidence of side effects was similar between the groups.

Considering ALS is an intractable, progressive disease with a poor prognosis that poses considerable impediments to daily life and greatly requires new treatment options, Eisai believes the agent can be useful in clinical settings for ALS given these results, and therefore has submitted an application for approval.

The results of Study 761 were presented at the 67th Annual Meeting of the American Academy of Neurology1 held in Washington D.C, the United States from April 18 to 25, 2015, and was presented at the 56th Annual Meeting of the Japanese Society of Neurology2 held in Niigata, Japan from May 20 to May 23, 2015

Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field. Furthermore, as a maker and discoverer of new drugs, Eisai is carrying out various initiatives including research into uncovering new indications and value for existing drugs such as mecobalamin in order to fulfill unmet medical needs in neurology and further contribute to increasing the benefit for patients and their families.

Notes: http://www.eisai.com/news/enews201535pdf.pdf


About Eisai

Eisai Co., Ltd. defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit https://www.eisai.com

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


May 27, 2015 15:15 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Drug Approval
Sectors: BioTech
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