— Iptacopan significantly slowed kidney decline in a phase III trial
July 17, 2026
• 2 min read
The FDA fully approved iptacopan (Fabhalta) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, drugmaker Novartis announced on Friday.
The complement inhibitor's conversion from accelerated to traditional approval hinged on findings from APPLAUSE-IgAN. The phase III study demonstrated a 48% reduction in the rate of estimated glomerular filtration rate (eGFR) decline compared with placebo over 24 months. Patients treated with iptacopan had an annualized mean change from baseline in eGFR of -3 mL/min/1.73 m² per year versus -5.7 mL/min/1.73 m² per year for those on placebo.
