Novartis reports Phase 3 data showing Fabhalta slowed kidney function decline by 50% and reduced kidney failure risk in IgA nephropathy over two years.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Novartis reported final two-year results from the Phase 3 APPLAUSE-IgAN trial (NCT04578834) showing that Fabhalta (iptacopan) significantly slowed kidney function decline in patients with IgA nephropathy (IgAN), meeting its primary endpoint and demonstrating consistent benefits across key renal outcomes. The findings were also published in the New England Journal of Medicine and presented at the World Congress of Nephrology 2026.
Fabhalta achieved a clinically meaningful improv
ement in estimated glomerular filtration rate (eGFR) slope. Over two years, the annual eGFR decline was –3.10 mL/min/1.73 m² with Fabhalta versus –6.12 mL/min/1.73 m² with placebo, representing a 49.3% slower decline in kidney function.
The therapy also reduced the risk of composite kidney failure events, with 21.4% of Fabhalta-treated patients experiencing events compared to 33.5% in the placebo group (hazard ratio 0.57), translating to a 43% lower risk. In addition, 40.7% of patients achieved proteinuria reduction targets versus 23.7% with placebo.
The safety profile remained consistent with previous findings, with low and comparable rates of adverse events and treatment discontinuation between Fabhalta and placebo groups.
Dr. Ruchira Glaser, Global Head of Cardiovascular, Renal and Metabolic Development at Novartis, stated that the two-year data confirm Fabhalta’s consistent ability to slow kidney decline in high-risk IgAN patients, reflecting sustained research efforts toward more targeted therapies that preserve kidney function.
Dr. Vlado Perkovic emphasized that persistent inflammation is a key driver of IgAN progression and highlighted that Fabhalta helps slow disease worsening while preserving kidney function and improving long-term outcomes.
Fabhalta is an oral Factor B inhibitor that selectively targets the alternative complement pathway, a central driver of inflammation and kidney damage in IgAN. By inhibiting this pathway, the therapy aims to reduce ongoing immune-mediated injury and slow disease progression.
Fabhalta has already received accelerated approval in the U.S. and China for reducing proteinuria in IgAN based on interim data from the same study. The two-year results have now been submitted to the FDA to support full approval and have been granted priority review.
IgA nephropathy is a progressive autoimmune kidney disease characterized by inflammation of the glomeruli and persistent proteinuria. Up to 50% of patients may progress to kidney failure within 10–20 years, highlighting the need for effective targeted therapies beyond standard supportive care.
References
Novartis IgAN data in New England Journal of Medicine show Fabhalta® slowed kidney function decline by 49.3%, 29 March 2026, Novartis IgAN data in New England Journal of Medicine show Fabhalta® slowed kidney function decline by 49.3% | Novartis
Jonathan Barratt et al, Iptacopan in IgA Nephropathy-Final 24-Month Data, New Eng J Med, Published March 28, 2026, Iptacopan in IgA Nephropathy — Final 24-Month Data | New England Journal of Medicine
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN), ClinicalTrials.gov ID NCT04578834, Study Details | NCT04578834 | Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | ClinicalTrials.gov
About Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.