FDA批准皮下注射药阿必鲁泰(Tanzeum)用于2型糖尿病

来源: 闽姑 2014-04-16 19:50:31 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 次 (2927 bytes)
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FDA批准阿必鲁泰用于二型糖尿病: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm

葛兰素史克(GSK,GlaxoSmithKline)研发的阿必鲁泰(Tanzeum (albiglutide) )是一种GLP-1(glucagon-like peptide-1,胰高血糖素样肽-1)受体激动剂,患者每周一次接受皮下注射。需辅以饮食和运动。Tanzeum的获批是基于全面III期Harmony项目的数据,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,证实药物有助显著改善糖化血红蛋白(HbA1c level)。但这个药不适用于一型糖尿病

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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 evaluated 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).
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via chart*****in.com






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