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6-K: Novartis Receives FDA Accelerated Approval for Fabhalta®

6-K: Novartis Receives FDA Accelerated Approval for Fabhalta®

6-K：诺华诺德获得FDA加速批准 Fabhalta®
美股SEC公告 ·  2024/08/09 04:30

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Novartis announced FDA accelerated approval for Fabhalta (iptacopan), the first complement inhibitor for reducing proteinuria in adults with primary IgA nephropathy (IgAN). In Phase III APPLAUSE-IgAN interim analysis, Fabhalta achieved a 44% proteinuria reduction from baseline, compared to 9% in placebo, demonstrating a 38% reduction versus placebo (p<0.0001).The approval is based on 9-month proteinuria reduction data, with continued approval contingent on verification of clinical benefit from the ongoing Phase III study measuring eGFR decline over 24 months, expected in 2025. The treatment targets patients with urine protein-to-creatinine ratio ≥1.5 g/g who are at risk of rapid disease progression.Novartis is advancing two additional IgAN therapies: atrasentan, which received FDA filing acceptance in Q2 2024, and zigakibart, currently in Phase III development. IgAN affects approximately 25 people per million worldwide annually, with up to 50% of patients with persistent proteinuria progressing to kidney failure within 10-20 years of diagnosis despite current standard care.
Novartis announced FDA accelerated approval for Fabhalta (iptacopan), the first complement inhibitor for reducing proteinuria in adults with primary IgA nephropathy (IgAN). In Phase III APPLAUSE-IgAN interim analysis, Fabhalta achieved a 44% proteinuria reduction from baseline, compared to 9% in placebo, demonstrating a 38% reduction versus placebo (p<0.0001).The approval is based on 9-month proteinuria reduction data, with continued approval contingent on verification of clinical benefit from the ongoing Phase III study measuring eGFR decline over 24 months, expected in 2025. The treatment targets patients with urine protein-to-creatinine ratio ≥1.5 g/g who are at risk of rapid disease progression.Novartis is advancing two additional IgAN therapies: atrasentan, which received FDA filing acceptance in Q2 2024, and zigakibart, currently in Phase III development. IgAN affects approximately 25 people per million worldwide annually, with up to 50% of patients with persistent proteinuria progressing to kidney failure within 10-20 years of diagnosis despite current standard care.
诺华公司宣布FDA加速批准Fabhalta（iptacopan），这是首个用于减少成人原发性IgA肾病（IgAN）患者蛋白尿的补体抑制剂。在III期APPLAUSE-IgAN的中期分析中，Fabhalta实现了基线蛋白尿减少44%，而安慰剂组为9%，展示了与安慰剂相比的38%减少（p<0.0001）。该批准基于9个月的蛋白尿减少数据，持续批准将取决于正在进行的III期研究的临床益处验证，该研究测量24个月内eGFR的下降，结果预计在2025年得出。该治疗针对尿蛋白与肌酐比率≥1.5 g/g的患者，且这些患者面临快速疾病进展的风险。诺华正在推进另外两种IgAN治疗药物：在2024年第二季度获得FDA申请接受的atrasentan，以及目前处于III期开发的zigakibart。IgAN每年全球影响约25人/百万人，其中高达50%的持续蛋白尿患者在诊断后10-20年内进展为肾衰竭，尽管目前已经有标准护理。
诺华公司宣布FDA加速批准Fabhalta（iptacopan），这是首个用于减少成人原发性IgA肾病（IgAN）患者蛋白尿的补体抑制剂。在III期APPLAUSE-IgAN的中期分析中，Fabhalta实现了基线蛋白尿减少44%，而安慰剂组为9%，展示了与安慰剂相比的38%减少（p<0.0001）。该批准基于9个月的蛋白尿减少数据，持续批准将取决于正在进行的III期研究的临床益处验证，该研究测量24个月内eGFR的下降，结果预计在2025年得出。该治疗针对尿蛋白与肌酐比率≥1.5 g/g的患者，且这些患者面临快速疾病进展的风险。诺华正在推进另外两种IgAN治疗药物：在2024年第二季度获得FDA申请接受的atrasentan，以及目前处于III期开发的zigakibart。IgAN每年全球影响约25人/百万人，其中高达50%的持续蛋白尿患者在诊断后10-20年内进展为肾衰竭，尽管目前已经有标准护理。
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