Author: fqlmuoi19127540

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 ... Read more