​阿斯利康达格列净治疗慢性肾病适应症获FDA优先审评资格

2021-01-10 医药魔方 医药魔方

1月6日,阿斯利康SGLT2(钠-葡萄糖协同转运蛋白2)抑制剂达格列净上市申请获FDA优先审评资格,用于治疗成人新确诊或恶化的慢性肾病(CKD),无论这些患者是否患有2型糖尿病(T2D)。达格列净有可

1月6日,阿斯利康SGLT2(钠-葡萄糖协同转运蛋白2)抑制剂达格列净上市申请获FDA优先审评资格,用于治疗成人新确诊或恶化的慢性肾病(CKD),无论这些患者是否患有2型糖尿病(T2D)。达格列净有可能成为首个获批用于治疗2型糖尿病和非2型糖尿病患者慢性肾病的SGLT2抑制剂。

FDA此次优先审评资格授予是基于代号为DAPA-CKD 的III期临床研究积极结果。DAPA-CKD研究的主要终点是估算肾小球滤过率(eGFR)持续降低≥50%,进展为终末期肾病(ESKD)和血管或肾病死亡的复合终点,研究中位时间2.4年。结果显示,在慢性肾脏病2-4期有蛋白尿升高的患者中,无论是否伴有2型糖尿病,与安慰剂相比,达格列净在标准治疗基础上可降低复合终点肾功能恶化、心血管或肾病死亡风险达39%(p<0.0001)。该研究也达到所有次要终点,包括与安慰剂相比,显著降低全因死亡风险达31%(arr=2.1%,p=0.0035)。在DAPA-CKD试验中观察到达格列净的安全性和耐受性与该药物已知的安全性一致。达格列净组与安慰剂组相比发生严重不良事件比例分别为29.5%和33.9%,少于安慰剂组;达格列净组无糖尿病酮症酸中毒发生,而安慰剂组有2例报道。慢性肾脏病(CKD)是一种严重疾病,患者肾功能呈进行性下降(以eGFR降低或肾脏损害或两者兼有为标志,并持续三个月以上),影响全球近7亿人口,且很多患者未被诊断。慢性肾脏病最常见病因为糖尿病、高血压,以及肾小球肾炎。患者一旦进入CKD最严重的阶段,即终末期肾病(ESKD)后,其肾脏严重受损,其肾功能发生进行性恶化,只能通过透析或肾脏移植来维持生命,大多数慢性肾脏病患者在进展至终末期慢性肾脏病之前,会因心血管疾病而死亡。  

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    2021-07-12 春江水暖

    新药

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