近日，美国FDA批准Albiglutide(商品名：Tanzeum)皮下注射剂结合饮食与运动用于改善2型糖尿病成人患者的血糖控制。在美国，大约有2400万人受2型糖尿病影响，占美国确诊糖尿病病例的90%以上。随着时间的推移，高血糖水平会增加严重并发症风险，包括心脏病、失明及神经和肾脏损害。 “对美国成千上万的2型糖尿病患者来说，阿必鲁泰是一种新的治疗选择，”FDA药品评价与研究中心药物评价II办公室主任、医学博士、公共卫生学硕士Curtis Rosebraugh称。“这款药物可以单独使用，或在糖尿病整个管理中添加到现有治疗方案中控制血糖水平。” 阿必鲁泰是一种胰高血糖素样肽-1(GLP-1)受体激动剂，一种帮助血糖水平正常化的激素。这款药物的安全性及有效性通过8项由2000多名2型糖尿病患者参与的临床试验得到评价。参与试验患者的HbA1c水平显示有改善（糖化血红蛋白A1c或称糖基化血红蛋白，是一种血糖控制指标）。 批准日期：2014年4月27日 公司：葛兰素史克公司 TANZEUM（albiglutide）用于注射，皮下使用 初始美国批准：2014年 警告： THYROID C-CELL肿瘤的风险请参见完整的BOXED警告的完整预定信息。 •无法在啮齿动物中评估albiglutide的致癌性，但其他胰高血糖素样肽-1（GLP-1）受体激动剂在临床相关暴露中引起甲状腺C细胞肿瘤。尚未确定啮齿动物中GLP-1受体-激动剂诱导的C细胞肿瘤的人类相关性。目前尚不清楚TANZEUM是否会导致人类甲状腺C细胞肿瘤，包括甲状腺髓样癌（MTC）。 TANZEUM禁用于有MTC病史或家族史的患者或2型多发性内分泌肿瘤综合征患者（MEN 2）。咨询MTC的潜在风险和甲状腺肿瘤的症状。 最近的重大变化 禁忌症：8/2017 警告和注意事项：8/2017 警告和注意事项，急性肾脏损伤：12/2017 作用机制 TANZEUM是GLP-1受体的激动剂，并增强葡萄糖依赖性胰岛素分泌。TANZEUM因此减慢胃排空。 适应症和用法 TANZEUM是一种GLP-1受体激动剂，表示作为饮食和运动的辅助手段，可改善2型糖尿病患者的血糖控制。 使用限制： 不推荐作为对饮食和运动控制不充分的患者的一线治疗。 尚未研究过有胰腺炎病史的患者。考虑有胰腺炎病史的患者的其他抗糖尿病治疗。 •不适用于治疗1型糖尿病或糖尿病酮症酸中毒。 不适用于既往有严重胃肠道疾病的患者。 尚未与膳食胰岛素联合研究。 剂量和用量 •在一天中的任何时间管理一次，而不考虑膳食。 •皮下注入腹部，大腿或上臂。 •每周一次皮下注射30毫克。在需要额外血糖控制的患者中，每周一次可以添加50mg剂量。 •如果错过剂量，则在错过剂量后3天内给药。 •参见完整的处方信息和患者使用说明，用于重建冻干粉末和给药。 剂量形式和强度 用于注射：单剂量笔中30mg或50mg。 禁忌症 •TANZEUM禁用于有甲状腺髓样癌病史的患者或2型多发性内分泌肿瘤综合征患者。 •对于对albiglutide或任何产品成分的先验严重超敏反应的患者禁用TANZEUM。 警告和注意事项 •甲状腺C细胞肿瘤：见盒装警告。 •急性胰腺炎：如果怀疑，立即停药。如果确认，请勿重新启动。考虑有胰腺炎病史的患者的其他抗糖尿病治疗。 •低血糖症：与胰岛素促分泌素（例如磺酰脲类）或胰岛素联合使用时可发生。在开始TANZEUM时考虑降低磺脲类药物或胰岛素剂量。 •超敏反应：发生严重的超敏反应（例如血管神经性水肿）。停止使用TANZEUM并立即就医。 •急性肾损伤：已发生上市后肾功能恶化和急性肾损伤的病例，其中一些需要进行血液透析。监测肾功能损害患者的肾功能，报告严重的胃肠道不良反应。 •宏观结果：TANZEUM尚未确定大血管风险降低的确凿证据。 不良反应 不良反应报告的患者治疗与TANZEUM，比服用安慰剂的患者更频繁地为上呼吸道感染，腹泻，恶心，注射部位反应，咳嗽，背痛，关节痛，鼻窦炎和流感≥5％。 药物相互作用 TANZEUM延迟胃排空。可能会影响同时使用的口服药物的吸收。 用于特定人群 •怀孕：TANZEUM可能导致胎儿伤害;仅在潜在利益证明对胎儿有潜在风险的情况下使用。 •急性肾损伤：建议不要调整剂量。监测肾功能损害患者的肾功能，报告严重的胃肠道不良反应。 包装提供/存储和处理 提供 TANZEUM有以下优势和包装尺寸： 30毫克单剂量笔（NDC 0173-0866-01）： 纸箱4个（包含4个29号，5毫米，薄壁针）：NDC 0173-0866-35 50毫克单剂量笔（NDC 0173-0867-01）： 纸箱4（包含4个29号，5毫米，薄壁针）：NDC 0173-0867-35 存储和处理 •分配之前：将笔存放在36°F至46°F（2°C至8°C）的冰箱中。 钢笔可以冷藏直至失效日期。 •分配后：将钢笔存放在36°F至46°F（2°C至8°C）的冰箱中。 患者可在使用前将钢笔在不超过86°F（30°C）的室温下储存长达4周。 将钢笔存放在原包装箱中直至使用。 •不要冻结。 •请勿在过期日期之后使用。 •重建后8小时内使用。 完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fcad939-76e7-49cf-af94-4e6aef17901f GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide) 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. Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said: “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.” 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 diabetes Diabetes is a global epidemic, affecting 382 million individuals globally, over 20 million of whom are in the US.1 Up to 95% of these patients have type 2 diabetes.1 Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels, known as hyperglycemia.  A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes.2,3  Treatment options include lifestyle changes such as increased physical activity and diet but, as the condition progresses, patients may require the addition of oral and injectable medications to control blood sugar levels and, ultimately, the use of insulin, either daily or with meals. 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. LIMITATIONS OF USE Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Tanzeum is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Tanzeum has not been studied in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin. Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use will soon be available at us.gsk.com.  Prior to the label being posted online, a copy of the label may be requested from the GSK Media or Investor Relations contacts listed in the “GlaxoSmithKline Inquiries” section at the end of this document. Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis.  A non-promotional factsheet, reviewed by the FDA, with more detailed safety information is available at www.TANZEUMREMS.com. Important Safety information for Tanzeum (albiglutide) The following information is taken from the highlights section of the US Prescribing Information.  Please see full Prescribing Information including boxed warning. BOXED WARNING: RISK OF THYROID C-CELL TUMORS Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). CONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. WARNINGS AND PRECAUTIONS Pancreatitis: Discontinue promptly if suspected. Do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: Can occur when used in combination with insulin secretagogues (e.g. sulfonylureas) or insulin. Consider lowering sulfonylurea or insulin dosage when starting Tanzeum. Hypersensitivity Reactions: Discontinue Tanzeum if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve. Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug. ADVERSE REACTIONS Adverse reactions, reported in ≥10% of patients treated with Tanzeum and more frequently than in patients on placebo, were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.