Novartis Receives FDA Approval for Fabhalta in IgA Nephropathy

Novartis today announced that the FDA has approved Fabhalta (iptacopan) for the treatment of adults with IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio ≥1.5 g/g. The approval was based on results from the Phase 3 APPLAUSE-IgAN trial, which demonstrated a statistically significant 38.3% reduction in proteinuria compared to placebo at 9 months. Fabhalta is an oral proximal complement inhibitor targeting Factor B of the alternative complement pathway. This approval provides patients with IgAN a new oral treatment option to reduce proteinuria and slow kidney disease progression.