2型糖尿病福音，降糖减肥两不误——诺和诺德在欧盟推出糖尿病鸡尾酒Xultophy

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糖尿病
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8 i! t" c# |, o; X3 Q; q9 O2015年1月20日讯 /生物谷BIOON/ --糖尿病巨头诺和诺德（Novo Nordisk）近日宣布，将瑞士定为商业化推出糖尿病鸡尾酒Xultophy（IDegLira）的首个欧盟国家，该药同时将在2015年间陆续在其他欧盟成员国上市。Xultophy是全球首个长效胰岛素和GLP-1受体激动剂复方药，兼具降糖和减肥功效，对广大2型糖尿病群体而言，是一大福音！业界预测，Xultophy将成为诺和诺德又一枚重磅产品，年销售峰值将突破10亿美元，如获FDA批准，前途更加不可限量。3 m9 Y2 Y+ _: o( l; E

5 g( Q+ L8 u4 k2 Z" d9 y) Z肥胖与糖尿病“密不可分”，肥胖既是糖尿病的早期症状，又是糖尿病的主要诱因。一方面，长期持续肥胖群体中糖尿病发病率明显升高。另一方面，在2型糖尿病群体中80%都是肥胖者。而Xultophy在临床试验中表现出的降糖和减肥利益及所提供的便利性，有望促使2型糖尿病患者群体更好地坚持治疗和主动管理自身病情。' Y1 k' N2 {. f/ R1 B( a+ z
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Xultophy是一种每日一次的单针注射制剂，于2014年9月获欧盟批准，用于2型糖尿病成人患者的治疗，该药适用于口服降糖药单药或联用基础胰岛素但血糖控制不佳的2型糖尿病患者群体。临床数据显示，对于基础胰岛素治疗控制不佳的2型糖尿病患者，Xultophy使糖化血红蛋白（HbA1c）水平显著降低1.9%，同时伴随平均2.7公斤的体重减轻，而低血糖概率与Tresiba媲美。
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Xultophy由Tresiba（insulin degludec，德谷胰岛素）和Victoza（liraglutide，利拉鲁肽）组成。其中，Tresiba是一种长效基础胰岛素；Victoza则属于胰高血糖素样肽1（GLP-1）受体激动剂，能够刺激天然胰岛素分泌，该药是诺和诺德的重磅产品，年销售额高达20亿美元，在GLP-1市场傲视群雄。4 ?. u* R; i' S0 m; t2 C7 ^: e7 {+ O# p
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然而，在美国市场，FDA于2013年因心血管风险拒绝批准Tresiba，并要求诺和诺德在提交长期预后数据证明Tresiba安全性之前，不能重新提交该药的上市申请。业界认为，Tresiba到2017年才会在美国上市。另外，根据FDA要求，任何复方产品必须由2种或更多已获批的药物组成，而Tresiba何时获批尚无时间表，因此Xultophy何时才能登陆美国尚不得而知。. t0 f- B! O. M# y/ V, B

6 W' Q$ E3 Y7 p糖尿病新药研发一直是生物技术领域的重点，GLP-1（胰高血糖素样肽-1）受体激动剂尤受关注，目前该领域竞争异常激烈，已上市的产品包括：诺和诺德的Victoza（liraglutide，利拉鲁肽，每日一次），百时美施贵宝和阿斯利康的Byetta（exenatide，艾塞那肽，每日2次）和Bydureon（长效缓释艾塞那肽，每周一次），赛诺菲的Lyxumia（lixisenatide，利西拉肽，每日一次），葛兰素史克的Tanzeum/Eperzan（albiglutide，阿必鲁肽，每周一次），礼来的Trulicity（dulaglutide，度拉鲁肽，每周一次）。（生物谷Bioon.com）
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英文原文：Switzerland first country to launch Xultophy® (IDegLira)
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Bagsværd, Denmark, 19 January 2015 - Today, Novo Nordisk announced Switzerland as the first country to launch Xultophy® (IDegLira) for people with type 2 diabetes.  Xultophy® is the first combination of a basal insulin [Tresiba® (insulin degludec)] and a GLP-1 analogue [Victoza® (liraglutide)]. Xultophy® is administered as a once-daily single injection independently of meals.  It is intended for use in adults with type 2 diabetes that are inadequately controlled with oral glucose-lowering treatments when these are used alone or together with basal insulin.* 1,23 }! c, B9 Z. l! r4 J* ]" c
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For people with type 2 diabetes uncontrolled on basal insulin, Xultophy® has demonstrated a significant 1.9% HbA1c reduction, mean weight loss of 2.7 kg and a low rate of hypoglycaemia (low blood sugar) comparable to insulin degludec.3
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"More than half of people with type 2 diabetes on basal insulin do not achieve glycaemic control and have an increased risk of developing complications," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The benefits that Xultophy® has shown and the convenience it provides may help motivate people with type 2 diabetes to better adhere to therapy and proactively manage their disease."; i. M# R8 q# S: ?3 w( u
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Type 2 diabetes is a progressive disease, which often requires people to initiate and then intensify insulin treatment to achieve or maintain their glycaemic targets over time.4
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"Even though insulin is a very effective treatment, people who live with type 2 diabetes may be reluctant to intensify their regimen because they prefer fewer injections or fear the potential side effects of weight gain and hypoglycaemia," said Professor Roger Lehmann, University Hospital Zurich, Switzerland. "The clinical programme for Xultophy® has shown consistent results in improving glycaemic control in patients uncontrolled on basal insulin and in patients who are not treated with insulin, providing hope for many people with uncontrolled type 2 diabetes and the physicians who treat them."
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Novo Nordisk expects to make Xultophy® available in other countries throughout Europe in 2015.
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About Xultophy® (IDegLira)1 m4 K  t7 S& b0 {$ X  _) k

' r2 O0 I8 H6 pXultophy® is a once-daily, single-injection combination product, consisting of Tresiba® (insulin degludec), a once-daily basal insulin analogue with an ultra-long duration of action, and Victoza® (liraglutide), a once-daily human GLP-1 analogue. The maximum dose of Xultophy® is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide).  Xultophy® can be administered independently of meals and has shown consistent results in improving glycaemic control in both insulin-naïve people as well as people with type 2 diabetes who are uncontrolled on basal insulin. For people uncontrolled on basal insulin therapy, Xultophy® has demonstrated a significant reduction in HbA1c of 1.9%, with a mean weight loss of 2.7 kg and a low rate of hypoglycaemia comparable to that of insulin degludec.3 Xultophy® is being investigated in the clinical trial programme, DUAL(TM).
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0 b3 }* ~. O, u4 kXultophy® was approved in Switzerland on 12 September 20142, and granted marketing authorisation by the European Commission for all 28 European Union member states on 18 September 2014.1