Novartis Obtains US FDA's Traditional Approval for Kidney Disease Drug Fabhalta

11:21 PM EDT, 07/16/2026 (MT Newswires) -- Novartis (NOVN.SW) said Friday it received traditional approval from the US Food and Drug Administration for Fabhalta as a treatment for adults with primary immunoglobulin A nephropathy, or IgAN, at risk of kidney function decline. The Swiss drugmaker supported its application for the medication with data from the phase 3 Applause-IgAN study, which showed statistically significant and clinically meaningful improvement in estimated glomerular filtration rate over two years, compared with placebo. The study also showed that the oral Factor B inhibitor has a safety profile in line with previous observations. Fabhalta, or iptacopan, was previously granted the US FDA's accelerated approval for the reduction of proteinuria in primary IgAN patients in August 2024.