Novartis Drug Fabhalta Slows Kidney Decline by Nearly Half in Phase III Study

Basel, Switzerland — Novartis announced positive two-year results from its Phase III APPLAUSE-IgAN study, demonstrating that its oral treatment Fabhalta significantly slowed kidney function decline by nearly 50% in adults with IgA nephropathy. The findings were corroborated by reports from American Pharmaceutical Review, MedPage Today, HCP Live, Clinical Trials Arena, FirstWord Pharma, and DocWire News. Each of the bullet points immediately below have been confirmed by at least four of the six respected sources we curated on this story.

• Over a two-year period, Fabhalta (iptacopan) significantly slowed the decline of kidney function by 49.3% compared to a placebo.
• The annualized estimated glomerular filtration rate (eGFR) slope for patients treated with Fabhalta was -3.10 mL/min/1.73 m², compared to -6.12 mL/min/1.73 m² for patients receiving a placebo.
• Fabhalta, which functions as an oral Factor B inhibitor of the alternative complement pathway, maintained a favorable safety profile that was consistent with prior clinical observations.
• The treatment had previously received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2024 specifically for reducing proteinuria in adult patients with primary IgA nephropathy who faced a risk of rapid disease progression.

Additional Details Reported

The complete two-year APPLAUSE-IgAN findings were published in the New England Journal of Medicine and simultaneously presented at the 2026 World Congress of Nephrology. In addition to slowing kidney function decline, the Phase III study indicated that Fabhalta consistently demonstrated a reduction in proteinuria for patients suffering from this progressive autoimmune kidney disease.

Based on the successful completion of the two-year data collection, Novartis has announced its intention to submit the final results to the FDA to support an application for traditional regulatory approval in 2026. The company is also continuing to expand its broader portfolio for IgA nephropathy, which features additional investigational compounds.

How we report: We select the day’s most important stories, confirm facts across multiple reputable sources, and avoid anonymous sourcing. Our goal is clear, balanced coverage you can trust—because transparency and verification matter for informed readers.