FDA Grants Traditional Approval to Iptacopan in Primary IgAN - Takeaways - MDSpire

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.

  • By

  • Kathryn Wighton

  • July 17, 2026

  • 2 min

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  • 1

    The FDA granted traditional approval to iptacopan (Fabhalta) for slowing kidney function decline in adults with primary IgA nephropathy.

  • 2

    Iptacopan previously received accelerated approval in August 2024 for reducing proteinuria in adults with primary IgA nephropathy.

  • 3

    The approval was based on findings from the phase 3 APPLAUSE-IgAN trial, showing a slower decline in kidney function with iptacopan.

  • 4

    Common adverse events associated with iptacopan include abdominal pain, dizziness, and nausea, with a risk of serious infections.

  • 5

    Fabhalta is available through a Risk Evaluation and Mitigation Strategy program requiring appropriate vaccinations before treatment.

Original Source(s)

FDA Grants Traditional Approval to Iptacopan in Primary IgAN

  • by Kathryn Wighton

  • July 17, 2026

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