Novartis says Fabhalta slows kidney function decline 49.3% in Phase III IgAN trial

Reuters13:16
Novartis says Fabhalta slows kidney function decline 49.3% in Phase III IgAN trial
  • Novartis reported final two-year Phase III APPLAUSE-IgAN results showing Fabhalta (iptacopan) slowed eGFR decline by 49.3% versus placebo.
  • Data were published in New England Journal of Medicine.
  • Results were presented as late-breaking data at 2026 World Congress of Nephrology.
  • Trial showed 43% lower likelihood of progression to kidney failure events, with HR 0.57.
  • Novartis said FDA granted priority review for traditional approval in IgA nephropathy.


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