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Basel, July 17, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta ® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression 1 . 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 IgAN 1 .
“IgAN is a chronic, immune-mediated disease leading to kidney failure that can have a severe impact on patients’ lives,” said 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.” Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN, one of the most common autoimmune kidney diseases 5 .
Up to 50 percent of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis and/or kidney transplantation, placing a significant burden on patients 6 -10 . “This milestone is a moment of great hope for the IgAN community,” said Bonnie Schneider, Director and Co-Founder, IgA Nephropathy Foundation.
“For patients and families impacted by this progressive disease, knowing that Fabhalta can help preserve kidney function brings renewed confidence and optimism for the future of the IgAN treatment landscape.” Data supporting approval 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 rat
Source: globenewswire
Country: United States