FDA Grants Traditional Approval to Iptacopan in Primary IgAN - Summary - 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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Objective:

To report the FDA's traditional approval of iptacopan for slowing kidney function decline in adults with primary IgA nephropathy.

Approach:
  • Approval Process: The approval was granted under priority review based on findings from the phase 3 APPLAUSE-IgAN trial.
Key Findings:
  • Iptacopan (Fabhalta) previously received accelerated approval in August 2023 for reducing proteinuria.
  • The annualized mean decline in estimated glomerular filtration rate was 3.0 mL/min/1.73 m² per year with iptacopan compared to 5.7 mL/min/1.73 m² per year with placebo.
  • Reductions in proteinuria were observed as early as 2 weeks and sustained over the treatment period.
Interpretation:

The approval reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN.

Limitations:
  • Iptacopan may increase the risk of serious infections caused by encapsulated bacteria.
  • Available only through a Risk Evaluation and Mitigation Strategy program requiring appropriate vaccinations before treatment.
Conclusion:

The ability to significantly slow kidney function decline is a critical treatment goal.

Sources:

Original Source(s)

FDA Grants Traditional Approval to Iptacopan in Primary IgAN

  • by Kathryn Wighton

  • July 17, 2026

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