FDA approves Fabhalta as first drug to significantly slow kidney decline in IgAN patients

The FDA has granted traditional approval to Fabhalta (iptacopan), a first-in-class complement inhibitor, for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). Fabhalta showed a 48% slower decline in kidney function compared to placebo over two years in clinical trials, addressing a critical need for treatments that preserve kidney health in this chronic disease. The drug targets the alternative complement pathway, a key driver of inflammation in IgAN, and offers hope for patients at risk of kidney failure. Novartis plans to support patient access with affordable pricing and ongoing research into related kidney therapies.