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Special Access Program assessing SCENESSE (afamelanotide) in adult patients with erythropoietic protoporphyria (EPP)

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Trial Profile

Special Access Program assessing SCENESSE (afamelanotide) in adult patients with erythropoietic protoporphyria (EPP)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 07 Jan 2025

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Erythropoietic protoporphyria
  • Focus Expanded access; Therapeutic Use

    • Most Recent Events

    • 23 Dec 2024 According to CLINUVEL media release, Canadian marketing authorization decision expected Q4 2025
    • 23 Dec 2024 According to CLINUVEL media release, Health Canada has validated and accepted for review of SCENESSE NDS. The SCENESSE NDS is now subject to review by Health Canada Health Products and Food Branch (HPFB), which sets a 300-day target to complete its evaluation and issue a decision on marketing authorization.
    • 08 Oct 2024 New trial record

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