Novartis announces Phase III study of Fabhalta showed superiority to placebo

Novartis (NVS) announced positive final results from APPLAUSE-IgAN, a Phase III study evaluating Fabhalta in adults living with IgA nephropathy, IgAN. Fabhalta, an oral alternative complement pathway inhibitor, demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate decline over two years. In APPLAUSE-IgAN, Fabhalta was well tolerated with a favorable safety profile in line with previously reported data. Full data from the APPLAUSE-IgAN final analysis will be presented at future medical meetings.