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Drugs. 2019 Mar;79(4):471-476. doi: 10.1007/s40265-019-01072-6.
Romosozumab (EVENITY™) is a humanised monoclonal antibody against sclerostin being developed by Amgen and UCB for the treatment of osteoporosis. On the basis of favourable results from several phase III trials in postmenopausal women with osteoporosis, and a single trial in men with osteoporosis, romosozumab is being considered for marketing approval in the US, EU and Canada, and was recently approved for marketing in Japan. This article summarizes the milestones in the development of romosozumab leading to this first approval for the treatment of osteoporosis in patients at high risk of fracture.
罗莫佐单抗（EVENITY）是人源化单克隆抗体，可特异性靶向骨硬化蛋白，由安进（Amgen）和优时比（UCB）联合开发，用于治疗骨质疏松症。基于几项针对绝经后骨质疏松症女性和一项针对男性骨质疏松症的 III 期临床试验的积极结果，罗莫佐单抗正在考虑在美国、欧盟和加拿大获得上市批准，并于近期在日本获得上市批准。本文总结了罗莫佐单抗开发过程中的重要里程碑，从而使其成为首个用于治疗高骨折风险骨质疏松症患者的药物。
