Novartis has received traditional approval from the US Food and Drug Administration (FDA) for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
Fabhalta is the first and only complement inhibitor approved for this indication and follows its accelerated approval in 2024 for reducing proteinuria in patients with primary IgAN. The approval was granted under the FDA’s priority review pathway.
The decision is supported by results from the Phase III APPLAUSE-IgAN trial, which demonstrated that Fabhalta slowed the decline in kidney function by 48% compared with placebo over two years. The treatment also showed clinically meaningful reductions in proteinuria as early as two weeks after initiation, with sustained benefits throughout the study period.
“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.”
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Fabhalta targets the alternative complement pathway, a key driver of inflammation and disease progression in IgAN. The study also confirmed a safety profile consistent with previous findings, with the most common adverse events including abdominal pain, dizziness, and nausea. Due to the risk of serious bacterial infections, the therapy is available through a Risk Evaluation and Mitigation Strategy (REMS) program requiring appropriate vaccinations before treatment.
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“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.”
