重磅新药!默沙东「来特莫韦片」在中国获批,用于巨细胞病毒的预防性治疗

2022-01-10 默沙东 默沙东

来特莫韦是全球首个且目前唯一获批用于异基因HSCT受者预防巨细胞病毒感染的药物。

近日,默沙东宣布,其新型非核苷类巨细胞病毒(CMV)抑制剂普瑞明 ®(来特莫韦片)已获得国家药品监督管理局(NMPA)批准,用于接受异基因造血干细胞移植(HSCT)的巨细胞病毒(CMV)血清学阳性的成人受者[R+]预防巨细胞病毒感染和巨细胞病毒病。普瑞明 ®(来特莫韦)是全球首个且目前唯一获批用于异基因HSCT受者预防巨细胞病毒感染的药物。

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92%,病毒复燃比例高达30~80%。在来特莫韦问世前,全球尚无批准用于异基因HSCT后预防巨细胞病毒感染的药物,虽然抢先治疗是控制巨细胞病毒的有效方法,但仍有很多异基因HSCT受者仍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

近年来,中国的造血干细胞移植水平不断进步,已经达到国际领先水准,但在巨细胞病毒的防控领域,仍然存在较大的未被满足的需求。国家血液系统疾病临床医学研究中心主任,北京大学血液病研究所所长黄晓军教授表示,来特莫韦的获批填补了这一领域的空白,为巨细胞病毒的预防性治疗模式奠定了基础,通过将病毒的防控端口前移,为医生解决造血干细胞移植过程中的巨细胞病毒相关问题、改善患者整体治疗效果提供了新的选择,也为我们进一步推动血液疾病的诊疗水平提升和学科发展带来了新的助力。

黄晓军教授还表示,除了本次在华获批的片剂,来特莫韦在国外还有注射剂型,两者相互配合,已经形成了成熟的临床治疗模式。部分异基因HSCT受者在治疗过程中存在口服药不耐受现象,注射剂型能够帮助这些患者提高药物吸收效率。通过不同剂型在给药方案上的互补,医生可以满足患者的个性化治疗需求,进一步提升巨细胞病毒管理的效果。

来特莫韦的出现改变了造血干细胞移植中的巨细胞病毒防控模式,作为在该领域的全球首款药物,它曾被美国FDA授予孤儿药资质,这次被加速引入中国,体现了中国政府通过前沿的医学成果满足患者需求的决心。默沙东全球高级副总裁兼默沙东中国研发中心总裁李正卿博士表示,作为一家研发密集型生物制药企业,默沙东始终以满足医疗需求为导向,勇于挑战不同领域的医学难题,推动科学的不断进步和突破。我们将继续追随患者的呼声,通过科研创新为广大患者带来福祉。

参考资料

1丁昊炜等. 造血干细胞移植患者巨细胞病毒感染危险因素和疗效分析.北京大学学报(医学版).2003;35(6):596-599

2 Styczynski J. Who Is the Patient at Risk of CMV Recurrence: A Review of the Current Scientific Evidence with a Focus on Hematopoietic Cell Transplantation. Infect Dis Ther. 2018;7(1):1-16

3Liu J, et al. Patients with refractory cytomegalovirus (CMV) infection following allogeneic haematopoietic stem cell transplantation are at high risk for CMV disease and non-relapse mortality. Clin Microbiol Infect. 2015;21(12):1121.e9-15.

4 陈娟,冯四洲.异基因造血干细胞移植后巨细胞病毒感染的研究现状.国际输血及血液学杂志.2020;43(5):374-382

5Jain NA, et al. The clinical and financial burden of pre-emptive management of cytomegalovirus disease after allogeneic stem cell transplantation-implications for preventative treatment approaches.Cytotherapy.2014;16(7):927-933

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    2022-01-07 yese
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    2022-01-07 wwzzly
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    2022-01-07 xxxx1054

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先天性巨细胞病毒(cCMV)感染不仅是儿童非遗传性感音神经性听力损失的主要原因,还与中枢神经系统异常有关。影像学诊断在对cCMV感染患儿听力损失的无创诊断中具有潜在价值。近日发表在Ear Hear期刊

Int J Pediatr Otorhinolaryngol:将先天性巨细胞病毒筛查纳入新生儿听力筛查项目中值得吗?

最近,有研究人员审查了将先天性巨细胞病毒(cCMV)筛查项目推广到全州范围内的永久性普及新生儿听力筛查(UNHS)项目中的潜在影响和障碍。

Pediatrics:无症状先天性巨细胞病毒感染的前庭、凝视和平衡障碍

先天性巨细胞病毒(cCMV)是感音神经性听力损失和发育障碍的主要非遗传性病因。由于在选定的cCMV患儿群体中,前庭受累的研究数据有限,cCMV前庭障碍的真实频率可能被低估。最近,研究人员确定了无症状c