Home / Health / FDA Approves Fabhalta for IgAN Kidney Protection
FDA Approves Fabhalta for IgAN Kidney Protection
17 Jul
Summary
- Fabhalta now has traditional FDA approval to slow kidney function decline in IgAN patients.
- Phase III study showed Fabhalta significantly reduced annual eGFR decrease over two years.
- The drug targets the alternative complement pathway, addressing a key driver of IgAN.
Novartis has received traditional FDA approval for Fabhalta (iptacopan), an oral treatment designed to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who face disease progression risks. This significant milestone follows an initial accelerated approval in August 2024 for reducing proteinuria.
The approval was supported by data from the Phase III APPLAUSE-IgAN study. This trial revealed that patients treated with Fabhalta experienced a slower annual decrease in estimated glomerular filtration rate (eGFR) of -3.0 mL/min/1.73m²/yr, compared to -5.7 mL/min/1.73m²/yr in the placebo group over a two-year period.
Fabhalta, a Factor B inhibitor, targets the alternative complement pathway, a critical component in IgAN pathology. While demonstrating consistent kidney health benefits, potential serious infections from encapsulated bacteria necessitate a Risk Evaluation and Mitigation Strategy (REMS) program in the US, including recommended vaccinations before treatment.
IgAN is a prevalent autoimmune kidney disease affecting approximately 25 new cases per million people globally each year. Novartis highlights Fabhalta's role in preserving kidney function by addressing the disease's underlying drivers, offering renewed hope to patients at risk of long-term kidney damage.
