Fabhalta Phase III APPLAUSE‑IgAN two‑year results show improved kidney function

Novartis reported final two‑year Phase III APPLAUSE‑IgAN results showing Fabhalta produced a statistically significant improvement in eGFR slope versus placebo. The findings were published in the New England Journal of Medicine and presented at the 2026 World Congress of Nephrology.

Novartis announced final two‑year results from the Phase III APPLAUSE‑IgAN study of Fabhalta in IgA nephropathy. The trial reported a statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope compared with placebo. Over two years, Fabhalta consistently outperformed placebo on key kidney outcomes, described by the company as a slowing of disease progression. The results were published in the New England Journal of Medicine and presented as late‑breaking data at the 2026 World Congress of Nephrology. Key results: - Fabhalta showed a statistically significant improvement in eGFR slope versus placebo. - Across two years, Fabhalta outperformed placebo on several kidney outcomes, reported as a slowing of disease progression. - The results were published in the New England Journal of Medicine and presented at the 2026 World Congress of Nephrology. - Vlado Perkovic, Steering Committee Co‑Chair of the APPLAUSE‑IgAN study, noted that persistent kidney inflammation drives progression and said the results show Fabhalta can reduce the risk of disease progression and help preserve kidney health. Summary: The two‑year data indicate Fabhalta slowed kidney‑function decline in patients with IgA nephropathy and improved a key marker of kidney health. Undetermined at this time.