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FDA Approves $2.59M Gene Therapy for SMA Patients

11/25/2025

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Story summary
  • The U.S. Food and Drug Administration approved Novartis' gene therapy Itvisma for patients aged 2 and older with SMA and SMN1 mutation.
  • Itvisma costs $2.59 million and is delivered directly to the central nervous system, unlike Zolgensma, which is given intravenously (IV).
  • Clinical trials showed significant improvements in motor function.
  • Thus, the approval could reduce reliance on chronic therapies for about 9,000 people in the United States living with SMA.