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。Atrasentan is an investigational potent selective oral ETA (endothelin A) receptor antagonist. Activation of the ETA receptor can lead to elevated proteinuria, which is related to kidney damage, fibrosis, and loss of kidney function in IgA nephropathy (IgAN).
According to the Zhītōng Financial APP, on November 26th, the CDE official website showed that Novartis's atrasentan hydrochloride tablets were domestically reported for listing, indicated for reducing proteinuria in adult patients with primary IgA nephropathy (IgAN) at risk of disease progression, and it has been granted priority review.
Screenshot Source: CDE Official Website
Atrasentan is an investigational potent selective oral ETA (endothelin A) receptor antagonist. Activation of the ETA receptor can lead to elevated proteinuria, which is related to kidney damage, fibrosis, and loss of kidney function in IgA nephropathy (IgAN). Atrasentan may be added to the current supportive therapy to reduce persistent proteinuria and protect the kidney function of a large patient population. Preclinical models also suggest that atrasentan can reduce inflammation and fibrosis in IgA nephropathy (IgAN).
On May 25th, Novartis announced the preplanned mid-term analysis results of the Phase III ALIGN study of atrasentan in the treatment of patients with IgA nephropathy (IgAN). Compared to patients receiving supportive treatment (maximum tolerated dose and stable dose of renin-angiotensin system [RAS] inhibitors), patients receiving atrasentan treatment had a 36.1% reduction in proteinuria at 36 weeks (measured by 24-hour urine protein-to-creatinine ratio [UPCR]) (p<0.0001). The study also showed that atrasentan had good safety, consistent with earlier reported data.
