APPLAUSE-IgAN: Iptacopan (Fabhalta) Exhibits 49.3% Slower eGFR Decline in IgAN Patients Than Placebo

Iptacopan (Fabhalta) demonstrated a 49.3% slower rate of estimated glomerular filtration rate (eGFR) decline versus placebo in the final 2-year results from the phase 3 APPLAUSE-IgAN trial.1

The results were announced by Novartis and presented as late-breaking data at the 2026 World Congress of Nephrology (WCN) in Yokohama, Japan. Additional findings included a 43% reduction in the likelihood of composite kidney failure events and 40.7% of iptacopan-treated patients achieving target proteinuria, compared with 23.7% in the placebo group.1

“Persistent kidney inflammation is a hallmark of IgAN, and a key driver of disease progression, leading to ongoing kidney damage and loss of function over time,” said Vlado Perkovic, MD, Professor of Medicine and Provost, University of New South Wales, and Steering Committee Co-Chair of the APPLAUSE-IgAN study in a statement. “These results are important because they show that Fabhalta can reduce the risk of disease progression, help preserve kidney health, and address outcomes associated with long-term disease burden.”1

Iptacopan is an oral factor B inhibitor designed to selectively target the alternative complement pathway, a key driver of inflammation and kidney damage in IgAN. Through factor B inhibition, iptacopan reduces ongoing complement-mediated injury and may slow disease progression.1,2

APPLAUSE-IgAN is a phase 3 double-blind, randomized, placebo-controlled trial that enrolled 443 adults with biopsy-confirmed IgAN and proteinuria ≥1 g/day despite optimized supportive therapy.2

Investigators randomly assigned patients in a 1:1 ratio to receive oral iptacopan 200 mg (n = 222) or placebo (n = 221), in addition to supportive therapy.2

The safety profile of iptacopan was consistent with previous findings, with similar rates of adverse events and treatment discontinuation between groups.2

“The two-year results demonstrate that Fabhalta consistently and meaningfully slows kidney function decline in high-risk patients with IgAN,” said Ruchira Glaser, MD, MS, Global Head, Cardiovascular, Renal and Metabolic Development, Novartis in a statement. “This progress reflects years of focused research and supports our efforts to advance more targeted treatment options to help preserve kidney health in people living with IgAN.”1

Iptacopan has received regulatory approvals in multiple complement-mediated diseases and is being evaluated across IgAN and other rare kidney conditions.1

References

1. Novartis Pharma AG. Novartis IgAN data in New England Journal of Medicine show Fabhalta® slowed kidney function decline by 49.3%. GlobeNewswire News Room. Published March 29, 2026. Accessed April 8, 2026. https://www.globenewswire.com/news-release/2026/03/29/3264223/0/en/Novartis-IgAN-data-in-New-England-Journal-of-Medicine-show-Fabhalta-slowed-kidney-function-decline-by-49-3.html

2. Perkovic V, Barratt J, Rovin B, et al. Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. New England Journal of Medicine. Published online October 25, 2024. doi:https://doi.org/10.1056/nejmoa2410316