Eisai Co., Ltd. announced  that the amyotrophic lateral sclerosis (ALS) treatment “Rozebalamin® for Injection25 mg” (mecobalamin) has been launched in Japan as a treatment for slowing progression of functionalimpairment in amyotrophic lateral sclerosis. The product received manufacturing and marketing approval in Japan on September 24, 2024, and was published in Japan’s National Health Insurance Drug Price List today.

This approval is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS),multicenter, placebo-controlled, double-blind, randomized Phase III clinical trial in 130 patients with ALS, that was conducted as an investigator-initiated trial 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, and Professor Satoshi Kuwabara (Coordinating Investigator), the Department of Neurology, Chiba University Graduate School of Medicine.1

ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 2 to 5 years from the onset of the disease.2 The number of patients in Japan is estimated to be approximately10,000.2 Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs.

Eisai considers neurology a therapeutic area of focus. As a human healthcare company, Eisai is committed to further addressing the diverse needs of, and increasing the benefits of, patients and their families by providing Rozebalamin as a new treatment option for ALS patients.