Eisai files for approval of mecobalamin ultra-high dose in Japan

Japanese pharma major Eisai (TYO: 4523).says 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. Under the trade name Methycobal, mecobalamin is already 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, Labor 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.