Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the amyotrophic lateral sclerosis (ALS) treatment “Rozebalamin® for Injection 25 mg” (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis.

卫材株式会社（总部：东京，首席执行官：Haruo Naito，“卫材”）今天宣布，肌萎缩侧索硬化症（ALS）治疗“注射用罗泽巴胺25 mg”（甲钴胺）已在日本推出，用于减缓肌萎缩侧索硬化症功能障碍的进展。

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.

该产品于2024年9月24日在日本获得生产和销售批准，并于今日发布在日本国家健康保险药品价格表上。这项批准是基于JETALS（日本超高剂量甲钴胺治疗ALS的早期试验），130例ALS患者的多中心，安慰剂对照，双盲，随机III期临床试验的结果，该试验是由一个研究小组发起的，该研究小组由德岛大学杰出教授Ryuji Kaji（首席研究员）和德岛大学生物医学科学研究生院神经病学系Yuishin Izumi教授（协调研究员）以及千叶大学医学研究生院神经病学系Satoshi Kuwabara教授（协调研究员）组成。ALS是一种顽固的，渐进的神经退行性疾病，由于运动神经元功能障碍导致严重的肌肉萎缩和肌肉无力。

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 approximately 10,000.2 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 medica.

由于死亡的主要原因是呼吸肌麻痹引起的呼吸衰竭，如果不使用人工呼吸器，死亡发生在疾病发作后约2至5年内。2日本的患者人数估计约为10000.2目前，尚无针对ALS的治疗方法，并且由于日本和国外批准的药物数量有限，因此这种疾病的药物严重未得到满足。