美國 TANZEUM®(albiglutide) for injection    歐盟 Epenzan®(albiglutide) for injection
Albiglutide is an investigational once-weekly injectable treatment for adult patients with type 2 diabetes.
GlaxoSmithKline (GSK) is developing albiglutide, a GLP-1 receptor agonist, for adult patients with type 2 diabetes. GSK announced it has filed for U.S. approval of this new once-weekly treatment, currently in Phase III clinical trials, and intends to submit a regulatory application in the European Union (EU).
About albiglutide
Albiglutide is an investigational biological, injectable form of human GLP-1.  GLP-1 is a peptide, normally secreted from the gastrointestinal tract during a meal, which helps the body to maintain normal blood-sugar levels and to control appetite.  The body works to quickly degrade GLP-1, resulting in its short duration of action. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced. Albiglutide is comprised of two copies of modified human GLP-1 that is fused to human albumin. This modified GLP-1 is designed to extend the action of GLP-1 and allow for once-weekly injections.
During clinical trials, albiglutide has been generally well tolerated with diarrhea being the most common adverse event.
GSK is developing albiglutide as a once-weekly injection using a pen injector to allow reconstitution by the patient and a fine gauge needle for subcutaneous administration.
Similar treatments, those in the same class of injectable GLP-1 medicines, include: Victoza, Byetta, Bydureon, and Amylin.
Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world. Ongoing studies will be complete in early 2013.
.Uses of Albiglutide
Albiglutide is an investigational once-weekly injectable treatment for adult patients with type 2 diabetes.
GlaxoSmithKline (GSK) is developing albiglutide, a GLP-1 receptor agonist, for adult patients with type 2 diabetes. GSK announced it has filed for U.S. approval of this new once-weekly treatment, currently in Phase III clinical trials, and intends to submit a regulatory application in the European Union (EU).
About albiglutide
Albiglutide is an investigational biological, injectable form of human GLP-1.  GLP-1 is a peptide, normally secreted from the gastrointestinal tract during a meal, which helps the body to maintain normal blood-sugar levels and to control appetite.  The body works to quickly degrade GLP-1, resulting in its short duration of action. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced. Albiglutide is comprised of two copies of modified human GLP-1 that is fused to human albumin. This modified GLP-1 is designed to extend the action of GLP-1 and allow for once-weekly injections.
During clinical trials, albiglutide has been generally well tolerated with diarrhea being the most common adverse event.
GSK is developing albiglutide as a once-weekly injection using a pen injector to allow reconstitution by the patient and a fine gauge needle for subcutaneous administration.
Similar treatments, those in the same class of injectable GLP-1 medicines, include: Victoza, Byetta, Bydureon, and Amylin.
Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world. Ongoing studies will be complete in early 2013.
ContributorsRxWiki Editorial Team
References"GSK Files for U.S. Approval of New Diabetes Drug", Reuters: 14 January , 2013
"GSK Announces Positive Data from Harmony 8 and Completion of Clinical Registration Package for Albiglutide in Type 2 Diabetes", GSK Press Release: 11 July 2012
SourceRxWiki
Managing EditorEric Ho, Pharm.D

葛兰素史克albiglutide（Tanzeum）成为第三个获得美国FDA批准上市的GLP-1受体激动剂
美国食品药品监督管理局(药监局)4月15日批准葛兰素史克的糖尿病新药Tanzeum(albiglutide)，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。
2型糖尿病在美国影响约2千4百万人和占被诊断糖尿病病例的90%以上。随着时间推移，高血糖水平可增加严重并发症风险，包括心脏病、失明和神经和肾损伤。
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。
Tanzeum有一个黑框警告警告在啮齿类研究中有些GLP-1受体激动剂曾观察到甲状腺肿瘤(甲状腺C-细胞肿瘤)，但不知道 Tanzeum是否引起甲状腺C-细胞肿瘤，包括在人中一种类型甲状腺癌被称为甲状腺髓样癌(MTC)，Tanzeum不应在有个人或家族MTC史或有2型多发性内分泌腺瘤综合征(一种疾病患者机体中有一种以上腺体肿瘤和他们容易患MTC)患者中使用。药监局 正在要求对Tanzeum进行以下上市后研究：
⑴一项临床试验评价在儿童患者中给药，疗效，和安全性；
⑵一项甲状腺髓样癌(MTC)病例注册至少15年时间以确定与Tanzeum相关MTC发生率的任何增加；
⑶一项心血管结局试验(CVOT)在有高基线心血管疾病风险患者中评价Tanzeum的心血管风险。
在临床试验中，用Tanzeum治疗患者最常见观察到的副作用是腹泻，恶心，和注射部位反应。
药监局批准Tanzeum有一个风险评估和减灾战略(REMS)，由交流计划告知卫生保健提供者伴Tanzeum严重风险组成。
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GSK公布糖尿病新药Tanzeum/Eperzan长期疗效和安全性数据
2014年6月15日，新获批的糖尿病药物Tanzeum/Eperzan（albiglutide）4个随机III期研究的二次分析新数据，albiglutide为每周一次的胰高血糖素样肽（GLP-1）受体激动剂，新数据表明，在这些研究中，继续接受albiglutide治疗的患者，在长达3年的时间内，继续表现出低的血糖水平，与一年期（52周）主要疗效终点数据一致。
在这4项研究中，血糖水平降低的主要终点定义为在治疗的52周中糖化血红蛋白（HbA1c）从基线水平的降低幅度，相关数据此前已公布。研究中的患者，仍继续接受随机治疗直到第3年，以进一步评估albiglutide的疗效和安全性。数据表明，这些研究中，安全性数据与1年期（52周）数据一致。常见不良反应包括恶心、腹泻、注射部位反应。
尽管目前在2型糖尿病患者中开展的III期临床试验通常为期6个月，但GSK旨在通过长期研究进一步评估albiglutide的疗效和安全属性。
关于albiglutide：
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。
albiglutide于2014年4月获FDA批准，商品名为Tanzeum，作为每日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。
albiglutide于2014年3月获欧盟批准，商品名为Epenzan。