智通财经APP获悉,今日,中国国家药监局药品审评中心(CDE)官网刚刚公示,默沙东(MSD)(MRK.US)申报的来特莫韦微片拟纳入优先审评,用于接受异基因造血干细胞移植(HSCT)的巨细胞病毒(CMV)血清学阳性的成人和6个月及以上且体重≥6kg的儿童受者[R+]预防巨细胞病毒感染和巨细胞病毒病。来特莫韦是一种新型非核苷类巨细胞病毒(CMV)抑制剂,该产品的片剂和注射剂剂型此前已经在中国获批上市。根据CDE公示,来特莫韦微片属于儿童新品种。
巨细胞病毒作为一种广泛存在的疱疹病毒,对造血干细胞移植患者的生命健康构成了严重威胁。研究表明,这些患者当中,巨细胞病毒的血清阳性率可高达90%以上。虽然抢先治疗是控制CMV的有效方法,但仍有很多异基因HSCT受者会出现难治性巨细胞病毒感染问题,且抢先治疗药物存在骨髓抑制、肾毒性等不良反应问题,增加了患者的死亡风险和医疗负担。
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