Novartis(US:NVS) Globenewswire·2025-10-16 05:15Core Insights - Novartis announced positive final results from the Phase III APPLAUSE-IgAN study, demonstrating that Fabhalta (iptacopan) significantly slows the progression of IgA nephropathy (IgAN) compared to placebo, as measured by the annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years [1][8]. Company Developments - Novartis plans to use the positive APPLAUSE-IgAN data to support submissions for Fabhalta in 2026, alongside advancing its multi-asset IgAN portfolio, which includes Vanrafia (atrasentan) and the investigational compound zigakibart [2][3]. - Fabhalta has received multiple regulatory approvals, including FDA and European Commission approvals for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and accelerated approval for reducing proteinuria in adults with IgAN at risk of rapid disease progression [6][8]. Industry Context - IgAN is a progressive autoimmune kidney disease with approximately 25 new diagnoses per million people globally each year, leading to significant health challenges, including a high risk of kidney failure [3][4]. - The need for targeted therapies is underscored by the limitations of supportive care, which often fails to slow disease progression [3][12]. - Novartis is committed to addressing unmet needs in kidney health, focusing on innovative treatments that target the underlying causes of kidney diseases [12][13].