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欧盟委员会批准BYETTA® (exenatide)为2型糖尿病治疗药物

2010-03-31 15:54:25 作者：新特药房来源：互联网浏览次数：268 文字大小：【大】【中】【小】

简介： Exenatide是 incretin mimetics.（模拟分泌物）的第一种抗糖尿病新药- Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc. AMLN礼来和安姆林药业公司，今天宣布，欧盟委员会已经批 ...

关键字：BYETTA® (exenatide)2型糖尿病

Exenatide是 incretin mimetics.（模拟分泌物）的第一种抗糖尿病新药
- Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc. AMLN礼来和安姆林药业公司，今天宣布，欧盟委员会已经批准治疗2型糖尿病的BYETTA® (exenatide) 上市。在前，欧洲医药办事处的人用医疗产品委员会(CHMP)已于2006年9月21日采用肯定的意见，礼来和安姆林药业公司，预计2007年在欧洲投入使用
现在Exenatide已获批准用于2型糖尿病人的辅助治疗，这些病人是已经服用足量的二甲双呱和磺脲类药物，血糖都不能控制。Exenatide被认为是 incretin mimetics.（模拟分泌物）的第一种抗糖尿病新药
欧盟委员会是根据评估Exenatide的全面资料做出决定的，这些资料包括跨越20多个国家，近4，000个2型糖尿病患者，35项研究，临床试验，显示Exenatide有助于患者改善长期空腹和餐后血糖，均测定了糖化血红蛋白（A1c），此外，在研究后期，还有继发性的体重减轻。
- 研究Exenatide和胰岛素相比，显示Exenatide与几种胰岛素在控制血糖方面有同样效果，这些用胰岛素的患者，都是对口服药物无效的。用Exenatide治疗的患者体重减轻，而用胰岛素的患者体重增加。
- 研究显示；Exenatide 是通过几种作用进行工作的，包括，只有当血糖高于正常时，才刺激胰岛素分泌，并恢复第一相的胰岛素反应，第一相的胰岛素反应，是胰腺中制造胰岛素细胞的正常过程，2型糖尿病患者这一反应丧失
- 英国百明翰大学教授Professor Anthony Barnet说“降低血糖至正常范围，减轻体重，恢复身体制造胰岛素细胞的能力，对2型糖尿病人是一个令人激动的进步“”对那些一种或多种口服药不能控制血糖的患者Exenatide是一个最佳选择””
- “估计欧洲有4千8百多万人患糖尿病“ 礼来欧洲公司执行主席Abbas Hussain说“糖尿病流行的快速增加以及新的治疗需求，再没有像今天如此严峻，exenatide的获得批准，对所有欧洲国家的保健专业人员和2型糖尿病患者选择新的药物，都是前进了一大步。糖尿病还有很大一部分的医疗需求未能得到满足，我们有义务领先为病人开发新的治疗“
- 以一个固定的剂量便于自我管理，exenatide是用公式来表示的。早餐和晚餐前皮下注射，或者每天两次主食之前。不需要因锻炼，进食或血糖检测结果的影响，调整剂量。exenatide用注射笔，每次剂量5毫克到10个毫克，患者开始第一个月用5毫克，然后10毫克，以进一步改善血糖控制。
- 已经证实，exenatide临床，试验有效，exenatide已经很好地耐受了一般的试验。据报告最常见的不良反应，是轻度和中度恶心，取决于患者是否继续治疗，绝大多数患者经过一段时间，恶心的频率和严重程度会减轻。与exenatide自我调整作用相一致，exenatide只在需要时才刺激胰岛素释放。因此减少了低血糖的可能。

BYETTA® (EXENATIDE) INJECTION

ABOUT BYETTA

BYETTA is the first FDA-approved agent in a class of diabetes therapies called GLP-1 receptor agonist. BYETTA is an injectable medication that exhibits many of the same glucoregulatory actions of GLP-1 (glucagon-like peptide-1), a naturally occurring incretin hormone.

GLP-1 stimulates the body’s ability to produce insulin in response to elevated levels of blood sugar; inhibits the release of a hormone called glucagon following meals; slows the rate at which nutrients are absorbed into the bloodstream; and enhances the feeling of fullness at meals to reduce the appetite.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.

BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

Clinical data from three important clinical studies with BYETTA underscore the combination of glucose control with potential weight loss. Highlights include:

At 30 weeks in an open-label, active-controlled comparator trial (N = 147), BYETTA delivered powerful A1C reductions of 1.5% with weight loss.¹
After 3 years in an open-label extension of registration trials (N = 217), most patients using BYETTA sustained glycemic control with weight loss:²
- 78% had A1C improvement (average 1% reduction from baseline of 8.2%).
- 84% had weight loss (average of 11.8 pounds from baseline of 219 pounds).

Up to 4X more patients reached an A1C ≤7% when BYETTA was added compared to patients on oral therapy alone (metformin or a thiazolidinedione ± metformin).^3,4
Sustained glucose control and progressive weight loss in patients using BYETTA for three years.
A blood glucose lowering effect comparable to insulin glargine—often with weight loss instead of weight gain—and a decrease in hypoglycemia compared with insulin glargine.

Important Safety Information for BYETTA^® (exenatide) injection

Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may happen with or without vomiting and may be felt going from your abdomen through to your back.
Your risk for getting low blood sugar is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYETTA.
BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. BYETTA may cause new or worse problems with kidney function, including kidney failure.
Before you use BYETTA, tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
Do not use BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Stop taking BYETTA and get medical help right away.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all the side effects with BYETTA. Talk to your healthcare provider about any side effect that bothers you or that does not go away.

Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and patient Medication Guide, at www.BYETTA.com.

References

1 Data on file, Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.

2 Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24(1):275-286.

3 DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28(5):1092-1100.

4 Zinman B, Hoogwerf BJ, Duran Garcia S, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007;146(7):477-485.