Lixisenatide: First Global Approval

Lixisenatide: First Global Approval
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DOI:
10.1007/s40265-013-0033-3
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发表时间:
2013-01-01
期刊:
影响因子:
11.5
通讯作者:
Keating, Gillian M.
Keating, Gillian M.
中科院分区:
医学1区
文献类型:
--
作者:
Elkinson, Shelley;Keating, Gillian M.

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赛诺菲正在开发每日一次餐时胰高血糖素样肽-1(GLP-1)受体激动剂利司那肽(Lyxumia(R)),用于治疗2型糖尿病。甘草酸属于一类GLP-1化合物,旨在模拟内源性激素GLP-1。天然GLP-1以葡萄糖依赖性方式刺激胰岛素分泌,以及抑制胰高血糖素产生和减缓胃排空。利司那肽每日一次皮下给药制剂已在欧盟、冰岛、列支敦士登、挪威和墨西哥获批用于治疗2型糖尿病,并正在美国、瑞士、巴西、加拿大、乌克兰、南非、日本和澳大利亚接受监管审查。本文总结了利司那肽开发的里程碑,导致首次批准用于2型糖尿病成人。
The selective once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Lyxumia (R)) is under development with Sanofi for the treatment of type 2 diabetes mellitus. Lixisenatide belongs to a class of GLP-1 compounds designed to mimic the endogenous hormone GLP-1. Native GLP-1 stimulates insulin secretion in a glucose-dependent manner, as well as suppressing glucagon production and slowing gastric emptying. A once-daily subcutaneous formulation of lixisenatide has been approved in the EU, Iceland, Liechtenstein, Norway and Mexico for the treatment of type 2 diabetes, and is under regulatory review in the USA, Switzerland, Brazil, Canada, Ukraine, South Africa, Japan and Australia. This article summarizes the milestones in the development of lixisenatide, leading to this first approval for use in adults with type 2 diabetes.