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]

Core Insights - Novartis announced positive final results from the late-stage APPLAUSE-IgAN study on Fabhalta (iptacopan) for adults with IgA nephropathy (IgAN), showing significant efficacy in slowing disease progression [1][2][8] - Fabhalta received accelerated approval in the U.S. in August 2024 for reducing proteinuria in adults with IgAN at risk of rapid disease progression [1] - The positive study results will support Novartis' regulatory submission for traditional FDA approval in 2026 [3][8] Drug Approvals and Pipeline - Fabhalta has received FDA and European Commission approval for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and is also approved in China for IgAN [4] - The drug is being evaluated for various rare kidney diseases, including atypical hemolytic uremic syndrome and lupus nephritis [5] - Novartis' portfolio includes other candidates like Vanrafia (atrasentan) and zigakibart for IgAN [5] Competitive Landscape - Travere Therapeutics' Filspari (sparsentan) is also approved for slowing kidney function decline in adults with primary IgAN [5][6] - Filspari received full approval in September 2024 based on long-term results from the PROTECT study [6] Financial Performance and Strategic Moves - Novartis has shown strong performance, with shares gaining 36.7% year-to-date compared to the industry's 7.5% growth [9] - The company is focused on strategic acquisitions, including the planned acquisition of Tourmaline Bio, Inc. for $1.4 billion, which will enhance its cardiovascular pipeline [11][12] - Novartis aims to strengthen its pipeline through both organic growth and acquisitions [11]

Core 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].