FDA Grants Novartis Fabhalta (Iptacopan) Traditional Approval Today Friday July 17 as the First and Only Complement Factor B Inhibitor Approved to Slow Kidney Function Decline in Adults With Primary IgA Nephropathy at Risk of Disease Progression: Phase 3 APPLAUSE-IgAN Data Showed a 3.02 mL/min/1.73 m² Per Year Difference in eGFR Slope for a 48% Slower Decline in Patients Receiving Iptacopan Versus Placebo, Following the August 2024 Accelerated Approval for Proteinuria Reduction; The Approval Extends the IgAN Competitive Set That Vera Therapeutics Entered on July 7 With Trutakna (Atacicept-Vymj) BAFF/APRIL Peptide-and-Fc Fusion Protein Accelerated Approval
Novartis (SIX: NOVN) announced Friday July 17, 2026 that the FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta is a first-in-class complement Factor B inhibitor (small molecule); the traditional approval converts the August 2024 FDA accelerated approval (which was based on proteinuria reduction) into a full label supported by kidney-function outcomes. The Phase 3 APPLAUSE-IgAN trial showed a 3.02 mL/min/1.73 m² per year difference in estimated glomerular filtration rate (eGFR) slope in the iptacopan arm versus placebo, translating to a 48% slower kidney-function decline. The approval extends the primary IgA nephropathy competitive set that Vera Therapeutics entered on July 7, 2026 when Trutakna (atacicept-vymj), a BAFF/APRIL-targeting peptide-and-Fc fusion protein, received FDA accelerated approval based on a 45.7% versus 6.8% reduction in urine protein-to-creatinine ratio in the Phase 3 ORIGIN trial. IgA nephropathy affects approximately 130,000-150,000 Americans and is the most common primary glomerular disease worldwide; roughly 40% of patients progress to end-stage renal disease within 20 years without effective treatment.