Novartis Gains FDA Approval for Innovative Kidney Drug

Novartis (NVS) has released an update.

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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