Novartis recently announced positive final results from the Phase III APPLAUSE-IgAN clinical trial. The final results from the APPLAUSE-IgAN Phase III trial demonstrate that Fabhalta (iptacopan) significantly slows kidney function decline in adults with IgA nephropathy (IgAN), establishing it as the first and only approved complement inhibitor for this progressive autoimmune kidney disease. Key opinion leaders interviewed by GlobalData emphasised that unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles.
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.
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Fabhalta met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in the annualised slope of eGFR decline versus placebo over two years. Fabhalta reduced proteinuria by around 38% compared to placebo, confirming its efficacy as a targeted therapy for this indication. The therapy was well tolerated, with a favourable safety profile consistent with previous data. Prior treatments often failed to slow disease progression, leaving patients with limited options beyond supportive care. 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.
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. According to GlobalData’s Drugs Database, 13 complement Factor B inhibitors are currently in active development for IgAN.
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By GlobalData
