日本厚生劳动省(MHLW)批准α-1蛋白酶抑制剂Lynspad治疗α-1抗胰蛋白酶缺乏症

2021-01-24 Allan MedSci原创

日本厚生劳动省(MHLW)已批准α-1蛋白酶抑制剂Lynspad(1000毫克静脉注射液)的生产和销售许可,用于治疗严重α-1抗胰蛋白酶缺乏症(AATD)。

α-1抗胰蛋白酶缺乏症(alpha-1 antitrypsin deficiency,AATD)是一种临床容易漏诊的遗传病,累及肺、肝脏甚至皮肤。在肺部,AATD导致慢性阻塞性肺疾病(COPD)。α-1抗胰蛋白酶是蛋白水解酶(弹性酶)及蛋白酶(胰蛋白酶、糜蛋白酶和凝血酶)的蛋白酶抑制剂。

AATD中的肺气肿是由肺内中性粒细胞弹性酶与弹性酶抑制剂AAT之间失衡所致。吸烟和感染增加了肺部的弹性酶负荷,因此增加了肺部降解。

生物制药公司Grifols近日宣布,日本厚生劳动省(MHLW)已批准α-1蛋白酶抑制剂Lynspad(1000毫克静脉注射液)的生产和销售许可,用于治疗严重α-1抗胰蛋白酶缺乏症(AATD)。

具体而言,Lynspad用于治疗诊断为严重AATD [血清α-1抗胰蛋白酶水平<50 mg / dL(通过浊度法测量)]以及患有肺部疾病(例如慢性阻塞性肺疾病(COPD)和肺气肿伴有气流阻塞)的患者。

 

原始出处:

https://www.firstwordpharma.com/node/1793958?tsid=4

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    2021-11-14 canlab
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    2021-12-04 gostraight
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