诺华COPD药物QVA149 首批3项III期研究达主要目标

2012-04-16 potato 生物谷

2012年4月2日，瑞士制药巨头诺华（Novartis）公司周一宣布，有关QVA149治疗慢性阻塞性肺病（chronic obstructive pulmonary disease，COPD）的首批3项III期研究均达到了预期的主要目标。 QVA149，一种具双重作用模式的支气管扩张剂，是诺华公司在其Breezhaler单剂量干粉吸入器中的第三个创新药物。诺华公司称，SHINE、BRIGHT

2012年4月2日，瑞士制药巨头诺华（Novartis）公司周一宣布，有关QVA149治疗慢性阻塞性肺病（chronic obstructive pulmonary disease，COPD）的首批3项III期研究均达到了预期的主要目标。

QVA149，一种具双重作用模式的支气管扩张剂，是诺华公司在其Breezhaler单剂量干粉吸入器中的第三个创新药物。

诺华公司称，SHINE、BRIGHT、ENLIGHTEN 3项III期研究证明了QVA149在治疗慢性阻塞性肺病中的潜能。这3项III期研究是IGNITE III期临床试验项目的关键组成部分，该项将为提交QVA149的新药申请（NDA）奠定基础。

SHINE研究表明，通过第一秒用力呼气容积谷值评价（in trough FEV1，Forced Expiratory Volume in 1 Second），QVA149比茚达特罗（indacaterol）及NVA237更具优势，此项研究达到了预期的主要目标。（indacaterol和NVA237均为诺华公司COPD药物）

BRIGHT研究表明，与安慰剂相比，患者的运动耐力得到了显着提高；ENLIGHTEN研究表明，QVA149具有与安慰剂相似的良好耐受性及安全性。

诺华制药开发负责人Tim Wright称，"IGNITE III期临床项目达到了预期的主要目标，这标志着在证明QVA149治疗COPD的潜力方面取得了重大进展，该药预计将成为我们强大的慢性阻塞性肺部药物产品中的第三个创新药。"

诺华表示，有关IGNITE研究项目的数据将在提交至今年晚些时候召开的医学大会。（生物谷bioon.com）

编译自：RTT News
http://www.rttnews.com/1852202/novartis-lung-disease-drug-qva149-meet-primary-endpoints-in-phase-iii-studies.aspx?type=qf

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2013-02-22 juliusluan78

#III#

55 0
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2012-11-14 HinsMax

#III期研究#

71 0
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2012-04-18 一叶知秋

#诺华#

65 0
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2012-04-18 jingyanzhu715_39486105

#COPD药物#

63 0
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2012-04-18 智智灵药

#III期#

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