Novartis strengthens IgAN position with Fabhalta trial results: GlobalData

Novartis recently announced positive final results from the Phase III APPLAUSE-IgAN clinical trial, demonstrating that Fabhalta (iptacopan) significantly slows kidney function decline in adults with IgA nephropathy (IgAN). The results establish Fabhalta as the first and only approved complement inhibitor for the progressive autoimmune kidney disease, strengthening Novartis’ position in the IgAN space, says GlobalData.

According to GlobalData’s Drugs Database, 13 complement Factor B inhibitors are currently in active development for IgAN.

While Fabhalta received accelerated FDA approval in August 2024 based on proteinuria reduction, the APPLAUSE-IgAN final results, demonstrating slowed estimated glomerular filtration rate (eGFR) decline, support submission for traditional FDA approval in 2026. This transition from accelerated to full approval is significant, as it confirms that the drug provides real-world kidney protection, not just biomarker improvement

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments, “The APPLAUSE-IgAN results demonstrate that targeted, disease-modifying therapy can preserve long-term kidney function, offering hope that early intervention may prevent progression to dialysis or transplant.”

Fabhalta met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in the annualised slope of eGFR decline versus placebo over two years. It reduced proteinuria by around 38 per cent compared to placebo, confirming its efficacy as a targeted therapy for this indication. The therapy was well tolerated, with a favorable safety profile consistent with previous data.

Jaddoo concludes, “The success of Fabhalta strengthens Novartis’s renal portfolio and supports the commercial development of its additional IgAN candidates, such as atrasentan and zigakibart, reinforcing its long-term competitiveness in the nephrology space.”