Novartis Announces Positive Phase 3 APPLAUSE-IgAN Results for Iptacopan in IgA Nephropathy

Novartis today announced positive results from the Phase 3 APPLAUSE-IgAN trial evaluating iptacopan in patients with IgA nephropathy (IgAN). The trial met its primary endpoint, demonstrating a statistically significant 38.3% reduction in proteinuria compared to placebo at 9 months. Iptacopan is an oral proximal complement inhibitor targeting Factor B of the alternative complement pathway. IgAN is the most common primary glomerulonephritis worldwide and a leading cause of kidney failure. These results support regulatory submissions for iptacopan in IgAN, potentially providing patients with a new oral treatment option.