诺华的Adakveo获得FDA批准治疗镰状细胞性疼痛

2019-11-18 不详 MedSci原创

诺华宣布其Adakveo(crizanlizumab)获得美国食品药品监督管理局(FDA)批准,用于减少镰状细胞病患者的疼痛发作频率。该药物以前称为SEG101,已被批准用于减少16岁及以上患有该疾病的成年和儿科患者的血管闭塞性危机(VOC)。

诺华宣布其Adakveo(crizanlizumab)获得美国食品药品监督管理局(FDA)批准,用于减少镰状细胞病患者的疼痛发作频率。该药物以前称为SEG101,已被批准用于减少16岁及以上患有该疾病的成年和儿科患者的血管闭塞性危机(VOC)。

此次批准标志着在该疾病领域,第一个获批通过与P-selectin结合发挥治疗作用的药物。P-选择素是一种细胞粘附蛋白,在多细胞相互作用中发挥重要作用,可导致血管闭塞。

此次批准是基于52周,随机,安慰剂对照的SUSTAIN试验的结果,该结果表明,与安慰剂相比,Adakveo大大降低了VOC的中位年度发生率,1.63比2.98,相当于降低了45%。

镰状细胞病中心的主任,SUSTAIN试验的主要研究者肯尼斯·阿塔加说:"我们知道这种药物可以重大且具有临床意义的方式减少镰状细胞性疼痛的发生频率。Crizanlizumab的获批对于患有这种严重疾病的人们而言是一项重大的改进。"

镰状细胞疼痛是由形成细胞簇的多细胞相互作用触发的,这些细胞簇可以阻断或减少流向器官的血液

原始出处:


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    2020-07-09 drj2003
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    2019-12-13 bugit
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    2019-11-20 般若傻瓜
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