Novartis Fabhalta (iptacopan) meets Phase III primary endpoint, slows kidney function decline in patients with IgA nephropathy (IgAN)

• In APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope vs. placebo over two years¹
  
  
• eGFR is key marker of kidney function; IgAN is progressive autoimmune kidney disease that leads to kidney failure in many patients^1-3 
  
  
• Fabhalta is first and only approved complement inhibitor for adults with IgAN and has potential to delay disease progression^4,5 
  
  
• Fabhalta received accelerated approval for reduction of proteinuria in adults with IgAN in US in 2024; data support 2026 submission for traditional FDA approval^4,5 

Basel, October 16, 2025 – 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 annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years¹.  

“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,” said Ruchira Glaser, Development Unit Head, Cardiovascular, Renal & Metabolic, Novartis. “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 year³. IgAN is highly debilitating as it leads to glomerular inflammation, proteinuria, and a gradual decline in eGFR². Up to 50% 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^2,6,7. Furthermore, people living with IgAN often face mental, social, and economic challenges^2,8. 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^3,9.