Novartis的药物Fabhalta减缓了IgA肾病患者的肾衰减,支持了2026年林业发展局的核准。 Novartis' drug Fabhalta slowed kidney decline in IgA nephropathy patients, supporting a 2026 FDA approval.

Novartis宣布了积极的第三阶段试验结果,表明其口服药物Fabhalta(iptacopan)明显减缓了患有IgA肾病的成年人肾功能下降的速度,这种肾上腺病是一种罕见的自发免疫性肾病。 Novartis announced positive Phase III trial results showing its oral drug Fabhalta (iptacopan) significantly slowed kidney function decline in adults with IgA nephropathy, a rare autoimmune kidney disease. APPLAUSE-IgAN 试验发现，与安慰剂相比，肾功能在两年内有统计学上的显着改善，该药物耐受性良好且与先前的安全性数据一致。 The APPLAUSE-IgAN trial found a statistically significant improvement in kidney function over two years compared to placebo, with the drug well-tolerated and consistent with prior safety data. 这些发现支持2026年计划提交FDA的传统批准. These findings support a planned 2026 FDA submission for traditional approval. 该药物已经获准用于IgAN和其他稀有肾脏疾病。 The drug is already approved for IgAN and other rare kidney conditions. 另外,APPEAR-C3G试验的数据显示,伊普塔科潘有效降低了蛋白尿和稳定了C3球球病患者的功能,导致FDA在2025年3月批准了这种超罕见疾病的第一种治疗方法. Separate data from the APPEAR-C3G trial showed iptacopan effectively reduced proteinuria and stabilized kidney function in patients with C3 glomerulopathy, leading to FDA approval in March 2025—the first treatment for this ultra-rare disease. 将在即将举行的医疗会议上介绍全面结果。 Full results will be presented at upcoming medical conferences.