Novartis announced the U.S. FDA has granted traditional approval for Fabhalta (iptacopan), positioning it as the first/only complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy (IgAN). The approval is a clear positive regulatory milestone that should strengthen the drug’s commercial outlook for a high-need indication.
Novartis announced the U.S. FDA has granted traditional approval for Fabhalta (iptacopan), positioning it as the first/only complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy (IgAN). The approval is a clear positive regulatory milestone that should strengthen the drug’s commercial outlook for a high-need indication.
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