Novartis announces two-year results from Phase III APPLAUSE-IgAN study

Novartis (NVS) announced final two-year results from the Phase III APPLAUSE-IgAN study of Fabhalta in IgA nephropathy, IgAN. Fabhalta demonstrated a statistically significant, clinically meaningful improvement in estimated glomerular filtration rate slope, a key marker of kidney function, compared with placebo. Fabhalta consistently outperformed placebo across key kidney outcomes over two years, demonstrating a slowing of disease progression and the potential to preserve kidney function in IgAN1. The results were published in the New England Journal of Medicine and simultaneously presented as late-breaking data at the 2026 World Congress of Nephrology, WCN. “Persistent kidney inflammation is a hallmark of IgAN, and a key driver of disease progression, leading to ongoing kidney damage and loss of function over time,” said Vlado Perkovic, MD, Professor of Medicine and Provost, University of New South Wales, and Steering Committee Co-Chair of the APPLAUSE-IgAN study. “These results are important because they show that Fabhalta can reduce the risk of disease progression, help preserve kidney health, and address outcomes associated with long-term disease burden.”