Fabhalta gains full FDA approval for proteinuria reduction in IgA nephropathy

The FDA granted full approval to iptacopan to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk for disease progression, according to a company press release. Iptacopan (Fabhalta, Novartis) is a first-in-class factor B complement inhibitor. Based on data from the APPLAUSE-IgAN trial, accelerated approval was granted in August 2024.