Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN

Novartis announced FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgAN. The drug demonstrated a 48% reduction in eGFR decline versus placebo over two years in the Phase III APPLAUSE-IgAN study. Fabhalta is the first complement inhibitor approved for this indication and represents a significant advancement in treating this chronic autoimmune kidney disease.