BASEL, July 17, 2026
Novartis announced that the U.S. 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) who are at risk of disease progression. The approval converts the medicine’s previous accelerated approval granted in 2024 for reducing proteinuria into full traditional approval based on confirmatory Phase 3 clinical data.
Phase 3 Study Demonstrates Kidney Function Preservation
The FDA approval is supported by results from the Phase 3 APPLAUSE-IgAN trial, where Fabhalta reduced the rate of kidney function decline by 48% compared with placebo over two years. The study also demonstrated rapid and sustained reductions in proteinuria, with clinically meaningful improvements observed as early as two weeks after treatment initiation.
First-in-Class Complement Pathway Inhibitor
Fabhalta selectively inhibits Factor B within the alternative complement pathway, targeting a key biological driver of inflammation and kidney damage in IgA nephropathy. By addressing the underlying disease mechanism, the therapy aims to preserve long-term kidney function and delay progression toward dialysis or kidney transplantation.
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Expanding Novartis’ Kidney Disease Portfolio
The approval further strengthens Novartis’ growing kidney disease portfolio, which also includes Vanrafia® (atrasentan) and the investigational therapy zigakibart. The company continues to focus on developing targeted therapies designed to address underlying disease biology while improving long-term outcomes for patients with chronic kidney diseases.
Source: Novartis press release
