Novartis' Fabhalta Proves Strong Kidney Protection in IgAN

According to Novartis' announcement, APPLAUSE-IgAN randomized Phase III trial results have provided positive final results showing that Fabhalta (iptacopan) was demonstrated to significantly slow decline in kidney function in adults with IgA nephropathy (IgAN).

The results establish Fabhalta as the first and only approved complement inhibitor for IgAN, a progressive autoimmune kidney disease, further cementing Novartis' leadership position in the IgAN landscape.

Data from GlobalData's Drugs Database indicates that there are 13 complement Factor B inhibitors under development in IgAN, demonstrating the burgeoning level of competition in this clinical space.

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Fabhalta gained accelerated FDA approval in August 2024 based on the ability to lower proteinuria, and with new final results demonstrating that it can significantly slow the decline of estimated glomerular filtration rate (eGFR) in adults with IgAN, Novartis intends to transition towards traditional FDA approval in 2026. This transitions Fabhalta to representing a key milestone and providing proof of concept that it provides some actual kidney protection as opposed to mostly improving kidney disease biomarkers.

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 successfully met its primary endpoint with a clinically meaningful improvement in annual eGFR decline vs placebo and a reduction of 38% in proteinuria vs placebo. The potential of Fabhalta combined with a favorable safety profile and consistent efficacy contributes positively to Novartis’ standing in nephrology, alongside bringing momentum to its next-generation IgAN candidates, atrasentan and zigakibart.