Novartis won FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy at risk of progression.
Approval was backed by the Phase III APPLAUSE-IgAN study showing a 48% slower eGFR decline vs. placebo over two years.
Fabhalta is the first complement inhibitor cleared for this endpoint in primary IgAN.
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