SCENESSE approved for EPP in Canada

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Stock Clinuvel Pharmaceuticals Ltd (CUV.ASX)
Release Time 13 Jul 2026, 8:34 a.m.
Price Sensitive Yes
 Clinuvel Pharmaceuticals Announces SCENESSE Approval in Canada
Key Points
  • SCENESSE approved for EPP in Canada
  • First systemic photoprotective drug for EPP
  • Long-term safety profile demonstrated
Full Summary

Clinuvel Pharmaceuticals Ltd. announced that Health Canada has approved SCENESSE (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). This marks the first systemic photoprotective drug for EPP in Canada, following approvals in Europe, the USA, and Australia. SCENESSE, which contains 16mg of afamelanotide, stimulates melanin production in the skin, providing photoprotection and acting as a strong antioxidant. The approval is based on extensive clinical data demonstrating SCENESSE's safety and efficacy, with over 21,000 doses administered globally.