FDA Grants Full Approval for Novartis Drug Fabhalta to Treat IgAN

Novartis announced that the FDA has granted traditional approval for Fabhalta (iptacopan), a complement inhibitor. This medication is now fully approved to slow the decline of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who face disease progression. The decision follows an earlier accelerated approval and is supported by Phase III study data showing Fabhalta significantly slowed eGFR decline over two years.