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Why Is Health Canada Delaying SCENESSE® Approval for Rare EPP Treatment?

1:11pm on Thursday 16th of October, 2025 AEDT Healthcare
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Why Is Health Canada Delaying SCENESSE® Approval for Rare EPP Treatment?

1:11pm on Thursday 16th of October, 2025 AEDT
Key Points
  • Health Canada delays SCENESSE® approval, review extended into 2026
  • Additional information requested despite prior approvals in US, Europe, Australia
  • SCENESSE® remains accessible in Canada through Special Access Program
  • Treatment targets rare metabolic disorder erythropoietic protoporphyria (EPP)
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