Novartis Fabhalta Receives Full FDA Approval as First Drug to Slow Kidney Decline in IgA Nephropathy

The FDA granted traditional approval for Novartis' Fabhalta (iptacopan), the first and only complement inhibitor shown to slow kidney function decline by 48% versus placebo in adults with primary IgA nephropathy — a chronic autoimmune kidney disease that affects roughly 25 per million people each year and can lead to kidney failure within 10 to 20 years.

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The US Food and Drug Administration 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, Novartis announced on July 17, 2026.

The first-in-class complement inhibitor received priority review after initially gaining accelerated approval in August 2024 for reducing proteinuria in primary IgAN.

Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN, one of the most common autoimmune kidney diseases. Up to 50 percent of patients with persistent proteinuria progress to kidney failure within 10 to 20 years, often requiring dialysis or transplantation.

The approval was based on Phase III APPLAUSE-IgAN study data. Results showed Fabhalta slowed estimated glomerular filtration rate (eGFR) decline by 48% versus placebo over two years — an annualized mean change from baseline of -3.0 mL/min/1.73 m²/yr compared with -5.7 mL/min/1.73 m²/yr for placebo. Clinically meaningful improvements in proteinuria were observed as early as two weeks, with sustained reduction over the treatment period.

Fabhalta targets the alternative complement pathway, where Factor B activation drives glomerular inflammation and kidney damage in IgAN. By inhibiting Factor B, the drug reduces complement-mediated injury and slows disease progression.

"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 at the University of Alabama at Birmingham. "The ability to significantly slow kidney function decline is a critical treatment goal."

The most common adverse events were abdominal pain, dizziness, and nausea. Fabhalta carries a risk of serious infections from encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy (REMS) program requiring vaccinations before treatment.

Novartis says nearly 100 percent of US patients pay $10 or less per month for the drug, which is part of a broader kidney disease portfolio that also includes Vanrafia (atrasentan) and investigational compound zigakibart.