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福音！欧盟扩大诺和诺德糖尿病鸡尾酒疗法Xultophy适应症，用于中度肾损伤

2016-09-08 佚名 生物谷

糖尿病鸡尾酒疗法
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近日，诺和诺德糖尿病鸡尾酒疗法Xultophy获得欧盟委员会批准扩大适应症，用于成人2型糖尿病治疗以及并发的中度肾损伤。 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

近日，诺和诺德糖尿病鸡尾酒疗法Xultophy获得欧盟委员会批准扩大适应症，用于成人2型糖尿病治疗以及并发的中度肾损伤。

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。Xultophy也是全球首个长效胰岛素和GLP-1受体激动剂复方药，2014年获得欧盟委员会批准，能够显著地控制患者的血糖状况，并且减少治疗相关的副作用，例如低血糖和体重增加。诺德诺德称，采用基础胰岛素治疗的2型糖尿病患者，经Xultophy治疗后，有四分之三的患者糖化血红蛋白（HbA1C）量下降了1.9个百分点，体重平均下降了2.7千克，并且和Tresiba相比，治疗产生的低血糖的症状显著减少。

此次Xultophy获得欧盟委员会批准扩大适应症主要是基于一项名为LIRA-RENAL的临床试验数据。该临床试验纳入了3500名2型糖尿病患者，试验充分证明了Xultophy的安全性和有效性，并且能显著改善患者并发肾损伤的症状。

欧洲糖尿病患者基数十分庞大，仅英国就有300万糖尿病患者，每年NHS用于糖尿病治疗的费用就高达140亿英镑。2型糖尿病患者中，将近40%的患者会并发不同程度的肾损伤，且目前针对糖尿病肾病的药物非常有限，此番诺和诺德的Xultophy获准扩大适应症，对这部分患者是一大福音。

尽管Xultophy在欧洲市场顺风顺水，但在美国市场的进展一直十分坎坷。2013年，FDA因心血管风险拒绝批准Tresiba，并告知诺和诺德，在提交长期预后数据证明Tresiba安全性之前，不能重新提交Tresiba的上市申请。诺和诺德预测，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，因此Xultophy何时登陆美国尚不得而知。

原始出处：

Europe expands use of diabetes drug Xultophy

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    2016-09-13 1dd8a7c5m95(暂无匿称)

    学习了，赞一个！！！

    0

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    2016-09-10 644982816_68283321

    #适应症#

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    2016-09-10 ms3046638856685384

    #损伤#

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    2016-09-10 12498768m17(暂无昵称)

    #鸡尾酒疗法#

    0

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    2016-09-10 qblt

    #鸡尾酒#

    0