Niidome Tetsuhiro, Ishikawa Yukio, Ogawa Tomoo, Nakagawa Masaki, Nakamura Yosuke
Eisai Co., Ltd.
Nihon Yakurigaku Zasshi. 2024;159(3):173-181. doi: 10.1254/fpj.24005.
Lecanemab is a humanized monoclonal antibody directed against human soluble amyloid-β aggregates. It was developed for the treatment of early Alzheimer's disease (mild cognitive impairment or mild dementia stage of Alzheimer's disease). Among the amyloid-β (Aβ) involved in Alzheimer's disease, Lecanemab selectively binds to the highly neurotoxic Aβ protofibrils, and is thought to reduce Aβ protofibrils and amyloid plaques (Aβ plaques) in the brain. The efficacy and safety of Lecanemab in early Alzheimer's disease were investigated in an international Phase II placebo-controlled study (Study 201) and an international Phase III placebo-controlled study (Study 301). Both studies included Japanese subjects. Lecanemab was given accelerated approval in the United States in January 2023, followed by traditional approval in July 2023. In Japan, it was approved for "control of the progression of mild cognitive impairment or mild dementia stage of Alzheimer's disease" in September 2023, and was added to the NHI drug price list in December 2023.
乐卡奈单抗是一种针对人可溶性淀粉样β蛋白聚集体的人源化单克隆抗体。它被开发用于治疗早期阿尔茨海默病（轻度认知障碍或阿尔茨海默病的轻度痴呆阶段）。在参与阿尔茨海默病的淀粉样β蛋白（Aβ）中，乐卡奈单抗选择性地结合具有高度神经毒性的Aβ原纤维，并被认为可减少大脑中的Aβ原纤维和淀粉样斑块（Aβ斑块）。在一项国际II期安慰剂对照研究（研究201）和一项国际III期安慰剂对照研究（研究301）中对乐卡奈单抗在早期阿尔茨海默病中的疗效和安全性进行了研究。两项研究均纳入了日本受试者。乐卡奈单抗于2023年1月在美国获得加速批准，随后于2023年7月获得传统批准。在日本，它于2023年9月被批准用于“控制阿尔茨海默病轻度认知障碍或轻度痴呆阶段的进展”，并于2023年12月被列入国民健康保险药品价格清单。
