Novartis Reports Major Kidney Breakthrough As Fabhalta Shows Strong 2-Year Benefits In IgAN Trial

Novartis announced the final two-year results from its Phase III APPLAUSE-IgAN trial, reporting that Fabhalta (iptacopan) delivered significant and sustained kidney benefits for patients with IgA nephropathy (IgAN). The treatment showed a marked improvement in the estimated glomerular filtration rate (eGFR) slope, demonstrating a slower decline in kidney function compared with placebo. 

The findings indicate that Fabhalta may help meaningfully slow the progression of this chronic kidney disease. The results were simultaneously published in the New England Journal of Medicine and presented as late-breaking data at the 2026 World Congress of Nephrology.

According to study investigators, Fabhalta consistently outperformed placebo across several key measures of kidney health. Vlado Perkovic, MD, Professor of Medicine and Provost at the University of New South Wales and Co-Chair of the study Steering Committee, noted that persistent kidney inflammation is a core feature of IgAN and drives long-term organ damage. He said the results demonstrate Fabhalta’s ability to reduce the risk of disease progression and help preserve kidney function over time.

The two-year analysis showed a clear difference in the rate of kidney function decline. Patients receiving Fabhalta recorded an average eGFR slope of –3.10 mL/min/1.73 m² per year, compared with –6.12 mL/min/1.73 m² per year for those on placebo. This represents a 49.3 percent slower decline for Fabhalta. The treatment also reduced the likelihood of major kidney failure events, with 21.4 percent of Fabhalta-treated patients experiencing these outcomes versus 33.5 percent in the placebo group. 

The hazard ratio of 0.57 corresponds to a 43 percent lower risk of reaching events such as major declines in eGFR, the start of dialysis, kidney transplantation, or death due to kidney failure. Fabhalta also demonstrated meaningful improvements in proteinuria. In the study, 40.7 percent of patients achieved the target urinary protein-to-creatinine ratio of less than 1 g/g, compared with 23.7 percent of patients receiving placebo.

Ruchira Glaser, MD, MS, Global Head of Cardiovascular, Renal and Metabolic Development at Novartis, said the findings reinforce the potential of Fabhalta to address an important unmet need for high-risk patients with IgAN. She noted that the progress reflects years of targeted scientific development and supports the company’s efforts to deliver more precise kidney therapies.

The safety profile of Fabhalta remained consistent with earlier data. Rates of adverse events and treatment discontinuations were low and comparable between the treatment and placebo groups. Fabhalta currently holds accelerated approval in the United States and China for reducing proteinuria in adults with IgAN, granted on the basis of interim results from the APPLAUSE-IgAN trial. 

Novartis has submitted the complete two-year dataset to the U.S. Food and Drug Administration for traditional approval, and the therapy has been granted priority review because of its novel mechanism and strong clinical outcomes. Alongside Fabhalta, Novartis continues to build its IgAN treatment portfolio, which also includes Vanrafia (atrasentan) and the investigational agent zigakibart, as part of its broader strategy to advance therapies for chronic kidney diseases.