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阿必鲁肽:全球首次获批。

Albiglutide: first global approval.

机构信息

Adis, Auckland, New Zealand.

出版信息

Drugs. 2014 Jun;74(8):929-38. doi: 10.1007/s40265-014-0228-2.

DOI:10.1007/s40265-014-0228-2
PMID:24861909
Abstract

Albiglutide (Eperzan® [EU]; Tanzeum™ [US]), a glucagon-like peptide 1 receptor agonist, has been developed by GlaxoSmithKline for the treatment of type 2 diabetes mellitus (T2DM). Albiglutide has received its first global approval in this indication in the EU, for use in combination with other antihyperglycaemic agents, including basal insulin, when these drugs and diet and exercise do not provide adequate glycaemic control, and as monotherapy in patients unable to take metformin due to contraindications or intolerance when diet and exercise alone do not provide adequate glycaemic control. Albiglutide has subsequently been approved for the second-line or later treatment of T2DM as an adjunct to diet and exercise in the US. This article summarizes the milestones in the development of albiglutide leading to this first approval for the treatment of T2DM.

摘要

阿必鲁肽(艾塞纳® [欧盟];替西珠单抗™ [美国]),一种胰高血糖素样肽 1 受体激动剂,由葛兰素史克公司研发,用于治疗 2 型糖尿病(T2DM)。阿必鲁肽在欧盟首次获得该适应证的全球批准,可与其他抗高血糖药物联合使用,包括基础胰岛素,当这些药物、饮食和运动不能充分控制血糖时,以及在因禁忌证或不耐受而不能服用二甲双胍的患者中作为单药治疗,当饮食和运动不能充分控制血糖时。此后,阿必鲁肽在美国被批准作为饮食和运动的辅助治疗,用于 T2DM 的二线或更后线治疗。本文总结了导致阿必鲁肽首次获批用于治疗 T2DM 的开发里程碑。

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Albiglutide: first global approval.阿必鲁肽:全球首次获批。
Drugs. 2014 Jun;74(8):929-38. doi: 10.1007/s40265-014-0228-2.
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Albiglutide: A once-weekly glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus.阿必鲁肽:一种用于2型糖尿病的每周一次胰高血糖素样肽-1受体激动剂。
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Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing.长效胰高血糖素样肽-1受体激动剂阿必鲁肽治疗2型糖尿病的潜力:一项探索每周、每两周和每月给药方案的随机对照试验
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Albiglutide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes.阿必鲁肽:一种用于治疗2型糖尿病的新型胰高血糖素样肽-1(GLP-1)受体激动剂。
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[Albiglutide (Eperzan): a new once-weekly agonist of glucagon-like peptide-1 receptors].阿必鲁肽(易安济):一种新型的每周一次胰高血糖素样肽-1受体激动剂
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HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea.HARMONY 4:一项随机临床试验,比较每周一次的阿必鲁肽与甘精胰岛素在单用二甲双胍或联用磺脲类药物血糖控制不佳的2型糖尿病患者中的疗效。
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Enhanced plasma half-life and efficacy of engineered human albumin-fused GLP-1 despite enzymatic cleavage of its C-terminal end.工程化人白蛋白融合胰高血糖素样肽-1(GLP-1)的血浆半衰期和疗效增强,尽管其C末端被酶切。
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Glucagon-like peptide-1 receptor: mechanisms and advances in therapy.胰高血糖素样肽-1 受体:作用机制与治疗进展。

本文引用的文献

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Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.在口服药物控制不佳的 2 型糖尿病患者中,每周一次的阿必鲁肽与每日一次的利拉鲁肽的疗效比较(HARMONY 7):一项随机、开放标签、多中心、非劣效性 3 期研究。
Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.
2
Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.用于治疗糖脂病的 GLP-1 受体激动剂的研发进展及未来选择
Bioorg Med Chem Lett. 2013 Jul 15;23(14):4011-8. doi: 10.1016/j.bmcl.2013.05.022. Epub 2013 May 16.
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Signal Transduct Target Ther. 2024 Sep 18;9(1):234. doi: 10.1038/s41392-024-01931-z.
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Eur J Pharmacol. 2022 Oct 15;932:175192. doi: 10.1016/j.ejphar.2022.175192. Epub 2022 Aug 16.
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The Neonatal Fc Receptor (FcRn): A Misnomer?新生儿 Fc 受体(FcRn):一个用词不当的名称?
Front Immunol. 2019 Jul 10;10:1540. doi: 10.3389/fimmu.2019.01540. eCollection 2019.
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