欧盟批准AZ的Fasenra治疗严重哮喘

2018-01-11 MedSci MedSci原创

阿斯利康(AstraZeneca)的biologic Fasenra在欧洲被批准用于治疗严重嗜酸粒细胞性哮喘。具体而言,尽管高剂量吸入皮质类固醇加长效β受体激动剂,但该药物的标签允许其在成人中的使用得到充分控制。阿斯利康说,Fasenra(benralizumab)是第一个获得批准的呼吸类生物制剂,它是一种招募自然杀伤细胞以消耗嗜酸性粒细胞的单克隆抗体,在体内维持药效的时间长达八周。批准是基于WI

阿斯利康(AstraZeneca)的biologic Fasenra在欧洲被批准用于治疗严重嗜酸粒细胞性哮喘。具体而言,尽管高剂量吸入皮质类固醇加长效β受体激动剂,但该药物的标签允许其在成人中的使用得到充分控制。阿斯利康说,Fasenra(benralizumab)是第一个获得批准的呼吸类生物制剂,它是一种招募自然杀伤细胞以消耗嗜酸性粒细胞的单克隆抗体,在体内维持药效的时间长达八周。批准是基于WINDWARD计划的结果,包括关键的III期加重试验,SIROCCO和CALIMA,以及ZONDA的III期OCS保留试验。SIROCCO和CALIMA的结果显示,每年哮喘发作率降低高达51%,而肺功能的改善与FEV1的变化有关,在第一次给予治疗剂量的benralizumab 4周后,FEV1的变化达到159毫升,且整个治疗周期都维持在该水平。此外,哮喘症状有改善,如气喘、咳嗽、胸闷和气短,在两种试验中,benralizumab治疗的患者和安慰剂组患者的不良反应频率相似。英国诺丁汉大学哮喘和呼吸内科教授Tim Harrison说:"许多患有严重嗜酸性哮喘的患者会出现虚弱的症状,并会增加急诊、住院

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    2018-06-27 gracezdd
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    2018-01-11 orangesking

    0