Novartis Fabhalta Receives FDA Traditional Approval to Slow Kidney Function Decline in Primary IgAN

Novartis Fabhalta Receives FDA Traditional Approval to Slow Kidney Function Decline in Primary IgAN

(IN BRIEF) Novartis has received FDA traditional approval for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy at risk of disease progression. Fabhalta is a first-in-class complement inhibitor targeting the alternative complement pathway. The approval is based on Phase III APPLAUSE-IgAN data showing that Fabhalta slowed eGFR decline by 48% compared with placebo over two years. It also delivered clinically meaningful reductions in proteinuria as early as two weeks, with sustained improvement over the treatment period. Novartis said the approval strengthens Fabhalta’s role in preserving kidney function and expands treatment options for patients with IgAN, a progressive autoimmune kidney disease that can lead to kidney failure, dialysis or transplantation.

(PRESS RELEASE) BASEL, 17-Jul-2026 — /EuropaWire/ — Novartis has announced that the U.S. Food and Drug Administration has granted traditional approval for Fabhalta®, also known as iptacopan, to slow kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk of disease progression.

Fabhalta is a first-in-class complement inhibitor and the first and only therapy in its class approved to significantly slow kidney function decline in primary IgAN. The treatment received approval under FDA priority review, following its initial accelerated approval in August 2024 for the reduction of proteinuria in primary IgAN.

The approval is supported by data showing that Fabhalta slowed estimated glomerular filtration rate decline by 48% compared with placebo over two years, demonstrating preservation of kidney function.

The therapy also showed clinically meaningful improvements in protein levels in urine as early as two weeks after treatment began, with reductions sustained over the treatment period.

Fabhalta targets the alternative complement pathway, whose activation is considered a key driver of inflammation associated with IgAN.

Dr Dana Rizk, Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham and a member of the APPLAUSE-IgAN Steering Committee, said IgAN is a chronic immune-mediated disease that can lead to kidney failure and significantly affect patients’ lives.

“The ability to significantly slow kidney function decline is a critical treatment goal,” said Dr Rizk.

She added that the approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, to help preserve kidney health in people with IgAN.

IgAN is one of the most common autoimmune kidney diseases. Each year, approximately 25 people per million worldwide are newly diagnosed with the condition.

Up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation. Novartis said this creates a significant burden for patients.

Bonnie Schneider, Director and Co-Founder of the IgA Nephropathy Foundation, said the approval represents a moment of hope for the IgAN 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,” said Schneider.

The FDA’s approval was based on data from the Phase III APPLAUSE-IgAN study. The study demonstrated statistically significant and clinically meaningful improvement in estimated glomerular filtration rate over two years.

Fabhalta showed an annualised mean change from baseline in eGFR of -3.0 mL/min/1.73 m² per year, compared with -5.7 mL/min/1.73 m² per year for placebo.

Novartis said Fabhalta consistently outperformed placebo across key kidney outcomes.

The APPLAUSE-IgAN study also showed a favourable safety profile for Fabhalta, consistent with previously reported data. The most common adverse events in patients with IgAN were abdominal pain, dizziness and nausea.

Fabhalta may increase the risk of serious infections caused by encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy programme, which requires appropriate vaccinations before treatment.

Victor Bultó, President, U.S., Novartis, said the approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression.

“This milestone underscores the importance of continued innovation for people living with IgAN and our commitment to addressing the underlying drivers of disease,” said Bultó.

Novartis said each person’s IgAN journey is different, and access to targeted therapies with different mechanisms of action can help physicians choose appropriate treatment options for their patients.

Alongside Fabhalta, Novartis is supporting the IgAN community through its growing portfolio, which includes Vanrafia® and the investigational compound zigakibart.

The company said it is committed to helping U.S. patients access Fabhalta through support programmes, with nearly all U.S. patients paying $10 or less per month.

Fabhalta is an oral Factor B inhibitor designed to selectively target the alternative complement pathway, one of several key drivers of glomerular inflammation and kidney damage in IgAN.

By inhibiting Factor B, Fabhalta is intended to reduce ongoing complement-mediated injury and slow disease progression.

Fabhalta has received regulatory approvals in multiple complement-mediated diseases, including IgAN, and is being evaluated across a range of rare kidney conditions.

Novartis said its work in kidney disease builds on a legacy of more than 40 years that began in transplant medicine. The company is focused on advancing treatments for kidney conditions with significant unmet need.

Its kidney disease portfolio targets underlying disease causes, with the aim of protecting kidney health and delaying or preventing dialysis and kidney transplantation.

Novartis said it is also working with patients, advocates, clinicians and policymakers to raise awareness, accelerate diagnosis and help patients receive appropriate care sooner.

About Fabhalta® (iptacopan)
Fabhalta (iptacopan) is an oral Factor B inhibitor designed to selectively target the alternative complement pathway, one of several key drivers of glomerular inflammation and kidney damage in IgAN2-4. By inhibiting Factor B, Fabhalta aims to reduce ongoing complement-mediated injury and slow disease progression. Fabhalta has received regulatory approvals in multiple complement-mediated diseases, including IgAN, and is being evaluated across a range of rare kidney conditions.

Novartis’ commitment to kidney diseases
Building on a legacy of more than 40 years that began in transplant, Novartis is on a mission to empower breakthroughs and transform care in kidney health, starting with kidney conditions that have significant unmet need.

Historically, these conditions have had considerably less funding and research, leading to a treatment landscape largely focused on reactive or end-stage disease management, often with significant physical, emotional, and financial burdens. Our portfolio targets the underlying causes of disease, with an aim to protect kidney health and delay or prevent dialysis and/or transplantation. Our goal is to help patients get back to living life on their terms – whether at work, in school, or with loved ones, and by partnering with patients, advocates, clinicians and policymakers, we aim to raise awareness, accelerate diagnosis, and get patients the right care, sooner.

Disclaimer
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About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

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References

1. FABHALTA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; July 2026.
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4. Chiu YL, Lin WC, Shu KH, et al. Alternative complement pathway is activated and associated with galactose-deficient IgA(1) antibody in IgA nephropathy patients. Front Immunol. 2021;12:638309. doi:10.3389/fimmu.2021.638309
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SOURCE: Novartis