GSK糖尿病新药Tanzeum获FDA批准

关键词:糖尿病新药,葛兰素史克,2型糖尿病,Tanzeum,albiglutide,GLP-1受体激动剂

2014年4月16日讯 /生物谷BIOON/ --葛兰素史克(GSK)4月15日宣布,糖尿病新药Tanzeum(albiglutide)获FDA批准,作为每周一次的皮下注射药物,辅助饮食和运动,用于改善2型糖尿病成人患者的血糖控制。GSK预计于2014年第三季度在美国推出Tanzeum。

Tanzeum的获批是基于全面III期Harmony项目的数据,该项目包含8项试验,涉及超过5000例患者,其中有超过2000例患者接受了Tanzeum的治疗。Harmony项目在不同阶段2型糖尿病患者群体中评估了albiglutide相对于常规2型糖尿病药物(包括胰岛素、二甲双胍、格列美脲、吡格列酮)的疗效和安全性。

Albiglutide为胰高血糖素样肽-1(GLP-1)受体激动剂,这是一种生物制品,开发用于2型糖尿病的治疗,每周皮下注射1次。该药与诺和诺德的Victoza、百时美施贵宝(BMS)和阿斯利康(AstraZeneca)Amylin单元的Byetta及Bydureon属于同一类注射型人胰升血糖素样肽-1(GLP-1)药物。Albiglutide最初由人类基因组科学公司(HGS)研发。GLP-1是一种重要的肠促胰岛素激素,帮助恢复正常的血糖水平。

在欧盟,lbiglutide于2014年3月获欧洲药品管理局(EMA)批准,品牌名为Epenzan。(生物谷Bioon.com)

英文原文:GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)

Issued: Tuesday 15 April 2014, London UK – LSE Announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle. Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.

The FDA approval of albiglutide is based on the results of GSK’s comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.

Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014.

Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan®, for use in adult patients with type 2 diabetes.

About TanzeumTM (albiglutide)Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

(责任编辑:lishuheng)

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