US approval for Fabhalta in IgAN

The US Food and Drug Administration (FDA) has granted accelerated approval for Novartis’ (NOVN: VX) Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study measuring reduction in proteinuria at nine months compared to placebo. 

Fabhalta achieved a 44% proteinuria reduction from baseline, compared with 9% in the placebo arm.