News|Articles|July 17, 2026

FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults

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Key Takeaways

Traditional approval was anchored on eGFR preservation rather than proteinuria surrogate, strengthening linkage to dialysis/transplantation risk reduction.
APPLAUSE-IgAN showed a 2.7 mL/min/1.73 m²/year benefit in eGFR slope versus placebo over two years.
Infection risk from encapsulated bacteria necessitates REMS, pre-treatment vaccination, and vigilance for meningococcal/pneumococcal disease.
Selective Factor B blockade of the alternative complement pathway positions iptacopan as a mechanistically targeted oral option in complement-driven IgAN.

FDA has converted Fabhalta's accelerated approval to a traditional approval for IgA nephropathy after confirmatory Phase III data showed the oral complement inhibitor slowed annual kidney function decline.

FDA granted traditional approval to Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin.

The approval converts Fabhalta's initial FDA accelerated approval, granted in August 2024 for reduction of proteinuria in primary IgAN, to a traditional approval following the completion of confirmatory trial data.¹ Fabhalta, a first-in-class oral complement inhibitor, received the new designation under a priority review.

What is the approval based on?

The traditional approval is supported by data from the Phase III Applause-IgAN study, which demonstrated statistically significant and clinically meaningful improvement in estimated glomerular filtration rate over two years.² Patients treated with Fabhalta showed an annualized mean change from baseline in eGFR of -3.0 mL/min/1.73 m² per year, compared to -5.7 mL/min/1.73 m² per year for placebo, a difference of 2.7 mL/min/1.73 m² per year.²

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The study showed a favorable safety profile consistent with previously reported data, as Fabhalta consistently outperformed placebo across key kidney outcomes.¹ The most common adverse events were abdominal pain, dizziness and nausea.

Fabhalta carries an increased risk of serious infections caused by encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy program requiring appropriate vaccinations before treatment initiation.¹

What is IgAN ?

IgAN is one of the most common autoimmune kidney diseases, affecting approximately 25 people per million worldwide annually. Up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, frequently requiring dialysis or kidney transplantation.¹

Why does this approval matter?

Traditional approval based on kidney function preservation marks a meaningful step beyond the accelerated approval granted on proteinuria reduction, which is a surrogate endpoint. Slowing eGFR decline is a more direct measure of kidney health and a closer proxy for long-term outcomes such as dialysis and transplantation.

"The ability to significantly slow kidney function decline is a critical treatment goal," said Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham and Applause-IgAN steering committee member. "This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health."

Bonnie Schneider, director and co-founder of the IgA Nephropathy Foundation, called the milestone a turning point for the patient community. "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," Schneider said.

How does Fabhalta work?

Fabhalta is an oral Factor B inhibitor that selectively targets the alternative complement pathway, one of the key drivers of glomerular inflammation and kidney damage in IgAN. By inhibiting Factor B, the drug aims to reduce ongoing complement-mediated injury and slow disease progression.¹

Novartis has obtained regulatory approvals for Fabhalta across multiple complement-mediated diseases and continues to evaluate it across a range of rare kidney conditions.

"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, U.S., Novartis.

Sources

Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN Novartis July 17, 2026 https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-receives-fda-traditional-approval-first-and-only-complement-inhibitor-significantly-slow-kidney-function-decline-primary-igan
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN) National Library of Medicine December 23, 2025 https://clinicaltrials.gov/study/NCT04578834

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