Novartis' Fabhalta Scores FDA Nod for Kidney Disease Therapy

Novartis received FDA approval for Fabhalta (iptacopan), a treatment for IgAN, a primary autoimmune kidney disease that significantly slows kidney function decline. This is the first complement inhibitor to receive FDA approval for this indication, with a 48% reduction in eGFR decline versus placebo over two years in the Phase III APPLAUSE-IgAN study.

The U.S. FDA granted NVS Novartis traditional (full) approval for Fabhalta (iptacopan) as the first and only complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy (IgAN) . IgAN is a chronic autoimmune kidney disease that causes progressive loss of kidney function and can ultimately require dialysis or transplant.

The approval was based on the Phase III APPLAUSE-IgAN study, in which Fabhalta slowed the decline in estimated glomerular filtration rate (eGFR) by 48% versus placebo over two years, an annualized decrease of -3.0 versus -5.7 mL/min/1.73m² . As a complement inhibitor, Fabhalta works by dampening the complement system, part of the immune response, from attacking the kidneys, and patients also saw clinically meaningful reductions in proteinuria.

The full approval, which converts an earlier accelerated approval for proteinuria reduction, is a meaningful win for NVS and strengthens its nephrology franchise. Investors will watch how Fabhalta competes in a crowded IgAN pipeline and whether delaying the need for dialysis translates into durable, premium-priced demand.

Novartis' Fabhalta Scores FDA Nod for Kidney Disease Therapy

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