治疗IgA肾病！诺华(NVS.US)阿曲生坦拟纳入优先审评
智通财经APP获悉，11 月 12 日，CDE官网显示，诺华(NVS.US)的盐酸阿曲生坦片拟纳入优先审评，适应症为用于降低有疾病进展风险的原发性免疫球蛋白A肾病(IgAN)成人患者的蛋白尿。
公开资料显示，阿曲生坦是一种在研的强效选择性口服ETA(内皮素 A)受体拮抗剂，ETA受体的激活会导致蛋白尿升高，这与IgAN中的肾脏损伤、纤维化和肾功能丧失有关。阿曲生坦有可能添加到目前的支持疗法中，以减少持续性蛋白尿并保护广大患者群体的肾功能。临床前模型也表明阿曲生坦可以减少IgAN中的炎症和纤维化。
值得注意的是，诺华另一款新药盐酸伊普可泮胶囊近期也在国内递交了用于IgAN的新适应症上市申请(JXHS2400053)，该药是目前全球首款获批用于降低有快速进展风险的原发性IgA肾病(IgAN)蛋白尿的补体旁路途径抑制剂，并有望在中国已获批的阵发性睡眠性血红蛋白(PNH)适应症基础上，加速拓展IgAN及其他肾脏领域适应症，为中国IgAN患者带来更加具有针对性的治疗方案。
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