Final two-year results from the Phase III APPLAUSE-IgAN study show that Novartis’s Fabhalta (iptacopan) slowed the decline of kidney function by 49.3% compared to placebo in patients with IgA nephropathy, according to data published in the New England Journal of Medicine. The drug also reduced composite kidney failure events by 43% and helped 40.7% of patients achieve sustained proteinuria reduction to below 1 g/g, compared to 23.7% on placebo.
The safety profile remained consistent with prior analyses, with mild-to-moderate infections, headache, diarrhea, and hyperlipidemia as common adverse events. Fabhalta previously received accelerated FDA approval for proteinuria reduction in IgA nephropathy, and the two-year data have been submitted for traditional approval with priority review status.
IgA nephropathy is a serious kidney disease with limited treatment options. The results represent a significant step forward for patients, demonstrating that Fabhalta can meaningfully slow disease progression and reduce the risk of kidney failure over a sustained period.