Novartis Receives FDA Accelerated Approval for Fabhalta (iptacopan) for the Reduction of Proteinuria in Primary IgA Nephropathy (IgAN)

Novartis receives FDA accelerated approval for Fabhalta (iptacopan) to reduce proteinuria in primary IgA nephropathy (IgAN), targeting the alternative complement pathway. Approval based on Phase III APPLAUSE-IgAN study interim analysis showing 44% reduction in proteinuria at 9 months vs. 9% with placebo. Continued approval contingent on eGFR data expected in 2025.