FDA Grants Traditional Approval to Iptacopan in Primary IgAN - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

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

Share

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

Related Content

Biomarker may flag early pregnancy risk

A protein was linked experimentally to trophoblast invasion.

Rare GI disease leads to 20-plus units of transfused blood

A rare intestinal lymphangioma caused life-threatening bleeding without typical laboratory features of protein-losing enteropathy

Nirsevimab may curb RSV severity

Real-world estimates showed protection across emergency, inpatient, and intensive care settings during Canada’s first universal immunization season.