FDA Approves Novartis’ Fabhalta for IgAN

The U.S. Food and Drug Administration (FDA) has granted traditional approval for Novartis’ Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

Fabhalta, a first-in-class complement inhibitor, received approval under a priority review designation after an initial FDA accelerated approval in August 2024 for the reduction of proteinuria in primary IgAN1.

“IgAN is a chronic, immune-mediated disease leading to kidney failure that can have a severe impact on patients’ lives,” explained Dana Rizk, M.D., Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham and APPLAUSE-IgAN Steering Committee Member. “The ability to significantly slow kidney function decline is a critical treatment goal. This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health.”

The approval of Fabhalta was based on data from the Phase III APPLAUSE-IgAN study. Results demonstrated statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years, with Fabhalta showing an annualized mean change from baseline in eGFR of -3.0 mL/min/1.73 m2/yr compared with -5.7 mL/min/1.73 m2/yr for placebo1. Fabhalta consistently outperformed placebo across key kidney outcomes.

“Today’s approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression, an outcome that matters deeply to patients at risk of long-term kidney damage,” said Victor Bultó, President, US, Novartis. “This milestone underscores the importance of continued innovation for people living with IgAN and our commitment to addressing the underlying drivers of disease.”