Novartis has secured traditional FDA approval for Fabhalta, also known as iptacopan, to slow kidney function decline in adults with primary immunoglobulin A nephropathy.
The approval targets adults with IgAN who are at risk of disease progression, marking a significant regulatory milestone for the Swiss pharmaceutical giant.
Fabhalta is a first-in-class factor B complement inhibitor, designed to reduce complement-mediated kidney injury and slow the overall progression of this autoimmune disease.
The FDA had previously granted Fabhalta accelerated approval in August 2024, focused on the reduction of proteinuria in primary IgAN patients, making this traditional approval a meaningful step forward.
Clinical trial results demonstrated statistically significant improvement in estimated glomerular filtration rate over two years, with Fabhalta recording an annualized mean change from baseline in eGFR of -3.0 mL/min/1.73 m² per year.
By comparison, the placebo group recorded an annualized mean change of -5.7 mL/min/1.73 m² per year, underscoring the clinical benefit Fabhalta delivered across key kidney function outcomes.
Final 24-month data from the APPLAUSE-IgAN study were published in The New England Journal of Medicine in March, lending additional scientific weight to the approval decision.
“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.
IgAN is one of the most common autoimmune kidney diseases globally, with approximately 25 people per million newly diagnosed each year, and many eventually progressing to kidney failure.
The APPLAUSE-IgAN study showed Fabhalta carries a favorable safety profile, with the most common adverse events being abdominal pain, dizziness, and nausea among IgAN patients.
Fabhalta is available only through a Risk Evaluation and Mitigation Strategy program, as it may increase the risk of serious infections caused by encapsulated bacteria, requiring vaccinations before treatment begins.
The drug was first approved by the FDA in December 2023 for paroxysmal nocturnal hemoglobinuria, a rare blood disorder, before expanding into renal indications.
Fabhalta also received FDA and European Commission approval in 2025 for C3 glomerulopathy, becoming the first treatment approved for that condition, alongside approvals in China and Japan.
Commercially, Fabhalta has demonstrated strong growth momentum, generating USD 169 million in sales during the first quarter of 2026, more than doubling the USD 81 million recorded in the same period a year earlier.