FDA Grants Traditional Approval to Iptacopan in Primary IgAN

Novartis reported less annual eGFR decline with iptacopan than placebo over 2 years in the phase 3 APPLAUSE-IgAN trial.

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The FDA granted traditional approval to iptacopan (Fabhalta) for slowing kidney function decline in adults with primary IgA nephropathy.
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Iptacopan previously received accelerated approval in August 2024 for reducing proteinuria in adults with primary IgA nephropathy.
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The approval was based on findings from the phase 3 APPLAUSE-IgAN trial, showing a slower decline in kidney function with iptacopan.
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Common adverse events associated with iptacopan include abdominal pain, dizziness, and nausea, with a risk of serious infections.
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Fabhalta is available through a Risk Evaluation and Mitigation Strategy program requiring appropriate vaccinations before treatment.

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