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CHMP建议批准GSK糖尿病新药albiglutide

来源:生物谷 2014-01-25 15:37

2014年1月25日讯 /生物谷BIOON/ --葛兰素史克(GSK)1月24日宣布,2型糖尿病新药albiglutide获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。

CHMP建议批准albiglutide,作为一种每周一次的皮下注射药物,用于改善2型糖尿病成人患者的血糖控制:(1)作为单药疗法,用于饮食和锻炼不能提供充分血糖控制、且因禁忌或不耐受而不适于二甲双胍治疗的2型糖尿病患者;(2)作为附加药物,与其他降糖药(包括基础胰岛素)联合用于单纯饮食和锻炼不能提供充分血糖控制的2型糖尿病患者。

Albiglutide为胰高血糖素样肽-1(GLP-1)受体激动剂,这是一种实验性生物制品,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。

目前,albiglutide也正在接受其他监管机构的审查,包括FDA,该药的美国处方药用户收费法(PDUFA)目标日期为2014年4月15日。

CHMP的积极意见,是基于一项全面的全球性研究项目,该项目包括8个III期研究,涉及超过5000例患者,将albiglutide与常用类别的2型糖尿病药物进行了对比,同时也评价了albiglutide用于不同疾病阶段的患者的治疗,以及用于有肾损害的患者。

在临床试验中,急性胰腺炎已被报道与albiglutide及其他GLP-1受体激动剂相关。研究中,albiglutide相关的最常见不良反应包括腹泻、恶心、注射部位反应。(生物谷Bioon.com)

英文原文:GSK receives positive opinion from the CHMP in Europe for once-weekly EperzanTM (albiglutide) for the treatment of type 2 diabetes

Issued: Friday 24 January 2014, London UK – LSE Announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for albiglutide, under the brand name EperzanTM.

The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes mellitus:

-As monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.

-As add-on combination therapy, in combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an investigational once-weekly type 2 diabetes treatment. GLP-1 is an important incretin hormone that helps normalise blood sugar levels.

“Today’s positive opinion is a major milestone towards offering people with uncontrolled type 2 diabetes a new option to help manage their condition and we look forward to the final decision of the European Commission in the coming months”, said Dr Carlo Russo, Senior Vice President, Research and Development at GSK. “Diabetes is a global health problem, affecting over 300 million people worldwide.  Albiglutide has the potential to help many patients with type 2 diabetes who struggle to control their blood glucose levels.”

A CHMP positive opinion is one of the last steps before marketing authorisation is granted by the European Commission. A final decision on marketing authorisation is anticipated during the first quarter of 2014.

Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014. Albiglutide is not approved for use anywhere in the world.

The CHMP positive opinion is based on an evaluation of a comprehensive global programme of studies involving over 5,000 patients. The programme included eight Phase III trials evaluating albiglutide against commonly-used classes of type 2 diabetes treatment and involved patients at different stages of the disease, as well as those with renal impairment, for up to three years.

In clinical trials, acute pancreatitis has been reported in association with albiglutide and other GLP-1 receptor agonists. The most frequent adverse reactions during clinical trials, which occurred in ≥5% of patients receiving albiglutide, were diarrhoea, nausea, and injection site reactions. If approved, albiglutide will not be appropriate for use in patients with a history of serious hypersensitivity to albiglutide or any of its excipients.

About albiglutide        

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing.  GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which, in turn, helps release insulin to control blood sugar elevations after eating.  In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced or absent.

Eperzan is a trademark of the GlaxoSmithKline group of companies.

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