Author: jefferyschmella
Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan
Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin (development code: E0302) for amyotrophic lateral sclerosis (ALS) in Japan, based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS: JETALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, published by a research team led by 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 submitted ... Read more