Novartis Fabhalta Iptacopan FDA Approval Becomes First Complement Inhibitor to Slow Kidney Decline in Primary IgAN

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The FDA has granted traditional approval to Novartis’ Fabhalta (iptacopan) — the first complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy. Phase III APPLAUSE-IgAN data showed a 48% slower eGFR decline versus placebo over two years.