Novartis Fabhalta wins FDA approval to slow kidney decline in primary IgA nephropathy

Novan, Inc.

Novan, Inc.

NOVN

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  • Novartis won FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy at risk of progression.
  • Approval was backed by the Phase III APPLAUSE-IgAN study showing a 48% slower eGFR decline vs placebo over two years.
  • Fabhalta is the first complement inhibitor cleared for this endpoint in primary IgAN.


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