Novartis Vanrafia® Phase III data support slowing of kidney function decline in patients with IgA nephropathy

Core Insights - Novartis announced final results from the Phase III ALIGN study, demonstrating that Vanrafia (atrasentan) significantly slows the decline in kidney function in adults with IgA nephropathy (IgAN) [1][3][9] - The study showed a difference of 2.39 ml/min/1.73m in estimated glomerular filtration rate (eGFR) change from baseline compared to placebo at Week 136, with a nominal p-value of 0.057 [1][9] - Vanrafia is positioned as a foundational therapy for IgAN, with a consistent safety profile and the ability to integrate into existing treatment plans [3][8] Study Results - At Week 132, Vanrafia demonstrated a 2.59 ml/min/1.73m change in eGFR from baseline compared to placebo, with a nominal p-value of 0.039 [2][9] - The ALIGN study provides the longest follow-up period in pivotal Phase III studies for IgAN, confirming the efficacy of Vanrafia across multiple timepoints and measures of kidney function [3][9] Product Information - Vanrafia is the first and only selective endothelin A receptor antagonist approved for primary IgAN, administered as a once-daily oral treatment [7][8] - It can be used alongside existing supportive care without the need for titration and does not require a Risk Evaluation and Mitigation Strategy (REMS) program [8] Company Commitment - Novartis is advancing its multi-asset IgAN portfolio, which includes Fabhalta (iptacopan) and investigational compound zigakibart, aiming to address significant unmet needs in kidney health [4][11] - The company has a legacy of over 40 years in kidney disease treatment and is focused on developing therapies that target the underlying causes of kidney diseases [11][12]