NVS Reports Positive Late-Stage Data on Kidney Disease Drug

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]