Fabhalta (iptacopan) - (APPLAUSE-IgAN)

July 17, 2026: Novartis announced the FDA granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of progression. The drug previously received accelerated approval in August 2024 for reduction of proteinuria in primary IgAN and this decision followed priority review.

Approval was supported by the Phase III APPLAUSE-IgAN study, which showed statistically significant, clinically meaningful preservation of kidney function over two years: annualized mean eGFR change from baseline was -3.0 mL/min/1.73 m²/year with Fabhalta vs -5.7 with placebo (a 48% slower decline vs placebo). Proteinuria improvements were observed as early as two weeks and were sustained over the treatment period.

Safety was described as favorable and consistent with prior data; most common adverse events were abdominal pain, dizziness, and nausea. Fabhalta may increase risk of serious infections caused by encapsulated bacteria and is available only through a REMS program requiring appropriate vaccinations prior to treatment.