Novartis (NVS) has released an update.
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Novartis AG has announced the FDA accelerated approval of Fabhalta (iptacopan) for reducing proteinuria in primary IgA nephropathy (IgAN), marking a significant advancement in the treatment of this chronic kidney disease. The approval is based on promising interim results from the Phase III APPLAUSE-IgAN study, which showed a significant reduction in proteinuria compared to placebo. This approval could potentially improve treatment for IgAN patients, who often face progression to kidney failure despite current treatments.
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