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IgA Nephropathy Drug With Novel Mechanism Wins FDA Approval

  • Novartis announced FDA's accelerated approval of Vanrafia for IgAN on April 2, 2025.
  • IgAN patients with rapid progression risk now have a new treatment option to reduce proteinuria.
  • Phase III data showed a 36.1% proteinuria reduction with Vanrafia versus placebo .
  • Richard Lafayette stated Vanrafia offers IgAN patients a new treatment option without a REMS requirement.
  • Vanrafia's approval expands IgAN treatment, though responses can vary among patients.
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Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P

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The Bradford Era broke the news in Bradford, United States on Thursday, April 3, 2025.
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