诺华公布两项最新慢阻肺 III期临床研究项目的阳性结果
- 根据EXPEDITION 试验结果,QVA149可改善中至重度慢阻肺患者的肺功能、呼吸困难和健康相关生活质量1-7
- GEM 1和2 研究显示, NVA237可使中至重度慢阻肺患者的肺功能获得显著且具有临床意义的改善 8,9
- 共有26篇诺华摘要在 2015年美国胸科学会(ATS)年会上公布,涉及多种呼吸产品。
诺华近日宣布了两个使用QVA149(茚达特罗/格隆溴铵)和NVA237(格隆溴铵)治疗中至重度慢性阻塞性肺病(简称慢阻肺,COPD)患者的关键III期临床试验项目的阳性结果。EXPEDITION(包括FLIGHT 1、2和3研究)和GEM项目均达到其主要和次要终点,试验结果在美国丹佛2015年5月15~20日举办的ATS国际会议上首次公布1-9。
来自EXPEDITION项目的数据显示,与安慰剂和QVA149所含的各个单组分(茚达特罗和格隆溴铵)相比,QVA149每天给药2次治疗12周后可使肺功能(FEV1 AUC0-12h)获得改善(p<0.001),达到主要终点1-2。进一步结果也证实诺华的这一双重支气管扩张剂可改善呼吸困难、总体生活质量和减少慢阻肺急救药物的使用1-4。此外,来自超过2,000例患者的最新汇总数据显示,与安慰剂相比,QVA149可显著改善给药后5分钟和15分钟 FEV15。
诺华制药全球研发负责人Vasant Narasimhan 表示,“这些数据证实QVA149可显著改善肺功能、呼吸困难,并且最重要的是可改善总体生活质量。鉴于美国和全球有数百万存在呼吸困难的慢阻肺患者,诺华致力于推动QVA149和其他新药的研发,以满足这些患者未被满足的重要治疗需求。”
在GEM 1和2研究中,与接受安慰剂治疗的中至重度慢阻肺患者相比,接受NVA237每天给药2次治疗的患者12周时肺功能(FEV1AUC0-12h)获得显著且具有临床意义的改善(p<0.001);达到主要终点8,9。此外,还在这些中至重度气流受限的患者中观察到慢阻肺症状和生活质量改善以及急救用药减少的情况8,9。
在EXPEDITION研究中,QVA149、QVA149所含的单组分和安慰剂的安全性大体相似6,7,在GEM研究中,NVA237的安全性与茚达特罗和安慰剂的安全性也大体相似8,9。
关于 QVA149
EXPEDITION 项目中所用的每日给药2次的QVA149(茚达特罗/格隆溴铵)已向美国监管部门递交注册申请。在美国之外,QVA149以商品名Ultibro® Breezhaler® 110/50 mcg销售,是每日给药1次的支气管扩张维持治疗药物,适用于缓解慢阻肺成人患者的症状11。每日1次Ultibro Breezhaler目前已获准在超过60个国家使用,这些国家包括欧盟和拉美国家、日本、加拿大、瑞士和澳大利亚。
Ultibro® Breezhaler®尚未在中国获得批准。
关于 NVA237
GEM试验中所用的每日给药2次的NVA237(格隆溴铵) 12.5 mcg已向美国监管部门递交注册申请。在美国之外,NVA237以商品名Seebri® Breezhaler® 50 mcg销售,是每日给药1次的支气管扩张维持治疗药物,适用于缓解慢阻肺成人患者的症状。每日1次Seebri Breezhaler目前已获准在超过80个国家使用,这些国家包括欧盟和拉美国家、日本、加拿大、瑞士和澳大利亚12。
Seebri® Breezhaler®尚未在中国获得批准。
关于 慢阻肺
据估计,全球的慢阻肺患者数量约为2.1亿例14,美国将近2700万例15。慢阻肺是一种慢性进展性肺部疾病,死亡率高14。除非采取相关措施管理慢阻肺的潜在危险因素,否则预计慢阻肺死亡率在未来10年将增加30%以上16。慢阻肺是美国第三大死亡原因,2010年有134,676名美国人死于慢阻肺17,预计到2030年,慢阻肺将成为全球的第三大死亡原因16。
慢阻肺可导致呼吸困难,并且慢阻肺症状可影响患者的活动能力和生活质量14,18。慢阻肺通常被认为是老年疾病,但数据表明50%的慢阻肺患者目前小于65岁,导致旷工增加、提前退休和参加工作的劳动力减少19,20。
参考资料
参考资料
1.Kerwin EM, Fowler Taylor A, Ayers T et al. QVA149 improves lung function to a greater extent than monocomponents in patients with poderate-to-severe COPD: The FLIGHT 1 Study. [ATS abstract 62856; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
2.Kerwin EM, Ayers T, Fowler Taylor A et al. QVA149 provides superior improvement in lung function versus its monocomponents in patients with moderate-to-severe COPD: the FLIGHT 2 study [ATS abstract 62690; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
3.Jones P, Mahler D, Fowler Taylor A, Ayers T et al. QVA149 show superior improvements in quality of life, as measured by SGRQ, compared with placebo in patients with moderate-to-severe COPD: the FLIGHT 2 study. [ATS abstract 62846; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
4.Mahler D, Fowler Taylor A, Ayers T et al. QVA149 reduces dyspnea in patients with moderate-to-severe COPD as measured by the transition dyspnea index: the FLIGHT 2 study [ATS abstract 61730; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
5.Banerji D, Fowler Taylor A, Ayers T et al. QVA149 shows rapid onset of bronchodilation versus placebo and its mono-components in patients with moderate-to-severe COPD: pooled data from the FLIGHT studies. [ATS abstract 62677; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
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7.Ferguson G, Fowler Taylor A, Ayers T et al. QVA149 is safe and well tolerated in patients with moderate-to-severe COPD: FLIGHT 3, a 52-week safety study. [ATS abstract 63609; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
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MCC: 150521213(2015年5月27日)