Fabhalta slows kidney function decline by 49.3% in IgA nephropathy patients, reducing kidney failure risk by 43%.

Novartis announced that Fabhalta (iptacopan) significantly slowed kidney function decline by 49.3% and lowered the risk of progression to kidney failure by 43% in IgA nephropathy (IgAN) patients over two years, based on Phase III APPLAUSE-IgAN study results published in the New England Journal of Medicine. Fabhalta also helped 40.7% of patients achieve sustained proteinuria reduction, a key marker of kidney health. The drug received priority review by the FDA for traditional approval, following earlier accelerated approval for proteinuria reduction. These results highlight Fabhalta's potential to preserve kidney function and address the underlying inflammation in IgAN, a progressive autoimmune kidney disease with limited treatment options.