葛兰素史克于3月26日宣布，欧盟委员会批准该公司GLP-1受体激动剂阿必鲁泰（Albiglutide,商品名Eperzan）用于治疗2型糖尿病成人患者。该公司计划于2014年下半年在欧洲几个国推出这款一周使用一次的治疗药物。Albiglutide是GLP-1类似物与白蛋白的融合蛋白，只需一周注射一次 。 

具体而言，阿必鲁泰作为单一治疗药物用于改善只靠饮食与锻炼不能提供充分的血糖控制，而对二甲双胍又有禁忌或耐受患者的血糖控制。此外，当其它降糖药物结合饮食与锻炼不能提供足够血糖控制时，阿必鲁泰可作为辅助药物与这些药物合并使用来改善血糖控制，这其中包括胰岛素。

葛兰素史克指出，这次的批准基于Harmony临床试验的结果，该试验由8项临床研究组成，参与的受试者有5000多人。这些试验对阿必鲁泰配合常用2型糖尿病药物（包括胰岛素）用于不同病期糖尿病患者及肾损伤患者进行了评价。去年发布的数据显示，在研究中阿必鲁泰与安慰剂及阳性对照药物相比，达到了降低糖化血红蛋白（HbA1c）水平的主要目标。葛兰素史克称，尽管很多糖尿病药物临床试验的周期只有6个月，但5项Harmony研究对患者的随访长达三年。

阿必鲁泰获批之前，欧洲药品管理局人用医药产品委员会于1月份给予这款药物积极推荐意见，而FDA预期会于4月15日发布对该药物的审批决定，此前FDA将这款药物审评期限推迟三个月，以评价葛兰素史克所提供的额外信息。

GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan® (albiglutide)

Issued: Wednesday 26 March 2014, London UK – LSE Announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide).  Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control 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 intolerance1
• 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.1

Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, me-tabolic and Neurosciences (CVM&NS) Franchise, said, “Diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50% of patients failing to meet their blood glucose targets.2,3The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well tolerated.”1,4

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle.  GLP-1 is an imp0rtant incretin hormone that helps normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent. 

The EMA authorisation of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight Phase III studies. The Harmony programme involved over 5,000 patients and eva1uated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment.   While many diabetes registration trials are just six months in duration, five of the Harmony trials included patient follow-up for up to three years.

GSK expects to launch albiglutide in several countries in Europe in Q3-4 2014 with additional launches to follow thereafter.

Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescr-ption Drug User Fee Act (PDUFA) target date is 15 April 2014. 

Safety information concerning the use of albiglutide in Europe

Albiglutide is not appropriate for use in patients with a history of hypersensitivity to the active substance or any of its excipients.1 

In clinical trials, the most serious adverse reaction observed with albiglutide was acute pancreatitis, which has also been reported with other GLP-1 receptor agonists.  Patients should be informed of the characteristic symptoms of acute pancreatitis.  If pancreatitis is suspected, albiglutide should be discontinued; if pancreatitis is confirmed, albiglutide should not be restarted.  Caution should be exercised in patients with a history of pancreatitis.1

The risk of hypoglycaemia is increased when albiglutide is used in combination with insulin secretagogues (such as sulphonylurea) or with insulin.  Therefore, patients may require a lower dose of sulphonylurea or insulin to reduce the risk of hypoglycaemia.1

The use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.  Albiglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and therefore it is not recommended in these patients.  In Europe, due to very limited experience of albiglutide in patients with severe renal impairment (n=19) or on dialysis, its use in this population is not recommended.1

The most frequent adverse reactions during clinical trials, which occurred in ≥5% of patients receiving albiglutide, were diarrhoea, nausea, and injection site reactions, including rash, erythema or itching at the injection site.1

For the EU Summary of Product Characteristics for Eperzan, please visithttp://ec.europa.eu/health/documents/community-register/index_en.htm. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the “GSK Enquiries” section at the end of this document.

Eperzan is a trademark of the GlaxoSmithKline group of companies.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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