Novartis (NYSE: NVS) announced final two-year results from the Phase III APPLAUSE-IgAN study of Fabhalta (iptacopan) in IgA nephropathy, showing statistically significant improvement in kidney function compared with placebo.

The study measured estimated glomerular filtration rate slope, a key marker of kidney function. Patients receiving Fabhalta showed a decline of 3.10 mL/min/1.73 m²/yr compared with 6.12 mL/min/1.73 m²/yr for placebo, representing a 49.3% slower decline in kidney function.

Composite kidney failure events occurred in 21.4% of Fabhalta patients versus 33.5% of placebo patients, representing a 43% lower likelihood. The composite endpoint included sustained decline in kidney function of 30% or more, sustained kidney function below 15 mL/min/1.73 m², dialysis initiation, kidney transplant, or death from kidney failure.

For proteinuria reduction, 40.7% of Fabhalta patients achieved the target of 24-hour urine protein-to-creatinine ratio below 1g/g compared with 23.7% of placebo patients.

The results were published in the New England Journal of Medicine and presented at the 2026 World Congress of Nephrology. The safety profile remained consistent with previous findings, with similar rates of adverse events and treatment discontinuation between Fabhalta and placebo.

Fabhalta received accelerated approval in the United States and China for proteinuria reduction in adults with IgA nephropathy based on interim study data. The company submitted the two-year data to the Food and Drug Administration for traditional approval and received priority review.