Novartis wins FDA traditional approval for Fabhalta in primary IgA nephropathy
NVS•FDA grants traditional approval for Fabhalta
Novartis won FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy.
Phase III APPLAUSE-IgAN data showed a 48% slower eGFR decline versus placebo over two years. Annualized eGFR change was -3.0 mL/min/1.73 m²/year versus -5.7 for placebo.
Fabhalta previously held accelerated approval in August 2024 for reducing proteinuria in primary IgA nephropathy.
The drug carries a serious infection risk and is distributed via REMS with required vaccinations.
