On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE:NVS) 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. In December 2023, the FDA approved Fabhalta as the first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria. This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study, which measured a reduction in proteinuria at nine months compared to placebo. Whether Fabhalta slows kidney function decline in patients with IgAN has not been established. The continued approval of Fabhalta may be contingent upon verification and description of ...