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Tanzeum (Albiglutide,阿必鲁泰皮下注射剂)

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软件语言：	简体中文	更新时间：	2014-04-26
版本号：	1.0	软件平台：	Win2000/WinXP/Win2003
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2014年4月15日，美国FDA批准阿必鲁泰(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）。
阿必鲁泰已作为一款单独药物和与其它2型糖尿病药物合并用药进行了研究，包括二甲双胍、格列美脲、吡格列酮及胰岛素。阿必鲁泰不应用于治疗1型糖尿病患者，以及血液及尿中酮体升高（糖尿病酮症酸中毒）的患者，也不能作为一线治疗药物用于不能通过饮食及锻炼来管理的糖尿病患者。
阿必鲁泰带有一项黑框警告，警告在某些使用GLP-1受体激动剂的啮齿类动物研究中观察有甲状腺肿瘤，但不清楚阿必鲁泰是否会引起甲状腺C细胞瘤，包括出现在人身上的甲状腺髓样瘤(MTC)。阿必鲁泰不应用于个人或家庭有MTC病史的患者，不能用于2型多发性内分泌腺瘤综合征（一种患者体内一种以上腺体出现肿瘤的疾病，使患者倾向于发展成MTC）患者。
FDA要求对阿必鲁泰进行以下上市后研究：
一项在儿科患者身上评价给药剂量、有效性及安全性的临床试验；
至少15年期的甲状腺髓样瘤登记，以确定甲状腺髓样瘤的发生率是否与阿必鲁泰有关联；
一项心血管结局试验(CVOT)，评价阿必鲁泰在心血管疾病高基线风险患者身上的心血管风险。
在临床试验中，阿必鲁泰用药患者出现的最常见副作用有腹泻、恶心和注射部位反应。
FDA批准阿必鲁泰附带一项风险评估和减轻战略（REMS），REMS含有一个沟通计划，以通知卫生保健提供商有关阿必鲁泰的严重风险。阿必鲁泰由位于特拉华州威尔明顿的葛兰素史克生产。
FDA NEWS RELEASE
For Immediate Release: April 15, 2014
Media Inquiries: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Tanzeum to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug eva luation II in the FDA’s Center for Drug eva luation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were eva luated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).
Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.
Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).
The FDA is requiring the following post-marketing studies for Tanzeum:
•a clinical trial to eva luate dosing, efficacy, and safety in pediatric patients;
•a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;
•a cardiovascular outcomes trial (CVOT) to eva luate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.
In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions.
The FDA approved Tanzeum with a Risk eva luation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.
Tanzeum is manufactured by GlaxoSmithKline, L.L.C., Wilmington, Del.

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