5 Key Takeaways

• 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.