Japan – Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS
Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW).
ALS is an intractable, progressive, neurodegenerative disease with significant unmet medical needs. In Japan, the estimated number of ALS patients is approximately 10,000.
Based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh- dose methylcobalamin (mecobalamin) in early onset ALS patients, led by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Eisai has initiated preparation on a new drug application (NDA) of ultrahigh-dose mecobalamin for ALS, and plans to submit a NDA during the fiscal year 2023 in Japan.
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, and ultimately further its contribution to improving the benefit of patients and their families.
Public Relations Department, Eisai Co., Ltd.
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