Novartis today announced positive final results from APPLAUSE-IgAN, a phase-III study evaluating Fabhalta (Iptacopan) in adults living with IgA nephropathy (IgAN). Fabhalta, an oral alternative complement pathway inhibitor, demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualised total slope of estimated Glomerular Filtration Rate (eGFR) decline over two years. 

Ruchira Glaser, Development Unit Head, Cardiovascular, Renal and Metabolic, Novartis, said, “Progressive diseases such as IgAN present an urgent need for interventions that can ultimately improve kidney health. Many people with IgAN commonly experience fear and anxiety of disease progression. We are excited about today’s positive phase-III APPLAUSE-IgAN results showing slowed eGFR decline, which add to the growing evidence of Fabhalta as a targeted therapy to preserve long-term kidney function, giving hope to people living with this condition.”?

Novartis intends to use these data to support Fabhalta submissions in 2026. Alongside Fabhalta, Novartis continues to advance its multi-asset IgAN portfolio, which also includes Vanrafia (Atrasentan) and investigational compound zigakibart.

IgAN is a progressive autoimmune kidney disease with approximately 25 per million people newly diagnosed worldwide each year. IgAN is highly debilitating as it leads to glomerular inflammation, proteinuria, and a gradual decline in eGFR2. Up to 50 percent of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation as part of long-term disease management. Furthermore, people living with IgAN often face mental, social, and economic challenges. Supportive care does not address the underlying causes of the disease and often fails to slow disease progression, reinforcing the need for more targeted therapies for IgAN.

In APPLAUSE-IgAN, Fabhalta was well tolerated with a favourable safety profile in line with previously reported data. Full data from the APPLAUSE-IgAN final analysis will be presented at future medical meetings.