Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2018 Feb;78(2):275-284. doi: 10.1007/s40265-018-0871-0.
Novo Nordisk has developed a subcutaneous formulation of semaglutide (Ozempic), a modified human glucagon-like peptide-1 (GLP-1) analogue, for the treatment of type 2 diabetes mellitus. It has been developed using Novo Nordisk's proprietary protein-acylation technology, and is administered using an injection device. Semaglutide lowers blood glucose by stimulating the release of insulin and also lowers body weight. Once-weekly subcutaneous semaglutide has recently been approved in the US, Puerto Rico and Canada, and has received a positive opinion in the EU for the treatment of patients with type 2 diabetes. It will be launched as the Ozempic Pen, a pre-filled device. Semaglutide is also under regulatory review in Japan and Switzerland for the treatment of type 2 diabetes. Clinical development for obesity, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease is underway worldwide. This article summarizes the milestones in the development of semaglutide leading to this first approval for type 2 diabetes.
诺和诺德公司开发了一种司美格鲁肽（Ozempic）的皮下制剂，这是一种经过修饰的人胰高血糖素样肽-1（GLP-1）类似物，用于治疗 2 型糖尿病。它是利用诺和诺德公司专有的蛋白质酰化技术开发的，通过注射装置进行给药。司美格鲁肽通过刺激胰岛素的释放来降低血糖，同时还能降低体重。每周一次的皮下注射司美格鲁肽最近已在美国、波多黎各和加拿大获得批准，并且在欧盟获得了治疗 2 型糖尿病患者的积极意见。它将作为预填充装置的 Ozempic Pen 推出。司美格鲁肽在日本和瑞士也正在接受监管审查，用于治疗 2 型糖尿病。该药在全球范围内用于肥胖症、非酒精性脂肪性肝炎和非酒精性脂肪性肝病的临床开发也正在进行中。本文总结了司美格鲁肽开发过程中的重要里程碑，最终使其首次获批用于 2 型糖尿病的治疗。
