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# Novartis’ Fabhalta Slows Kidney Function Decline
- URL: https://www.fdaweb.com/novartis-fabhalta-slows-kidney-function-decline/
- Published: 2025-10-16T12:00:00.000Z
- Updated: 2026-09-14T15:24:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160052

Novartis is reporting favorable data on its oral complement inhibitor Fabhalta (iptacopan) in certain patients with IgA nephropathy (IgAN). Its Phase 3 APPLAUSE-IgAN trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful slowing of kidney function decline in adults with IgAN, Novartis says.

The study measured the rate of decline in estimated glomerular filtration rate (eGFR) — a key indicator of kidney health — over two years, showing Fabhalta’s superiority over placebo. The company says the results support the drug’s potential to delay disease progression in patients with this chronic autoimmune condition.

Fabhalta is reportedly the only complement inhibitor approved in the U.S. for adults with IgAN. It received accelerated approval in 2024 to reduce proteinuria, a marker of kidney damage, in adults at risk of rapid disease progression. Novartis says it plans to use the new Phase 3 data to support a traditional FDA approval submission next year.

IgA nephropathy affects roughly 25 people per million each year and can lead to kidney failure in up to half of patients within two decades of diagnosis, according to Novartis. Current treatments primarily focus on supportive care, often failing to halt disease progression, it notes.