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A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

Trial Profile

A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2019

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Erythropoietic protoporphyria
  • Focus Registrational; Therapeutic Use
  • Sponsors Clinuvel Pharmaceuticals
  • Most Recent Events

    • 09 Oct 2019 According to a Clinuvel Pharmaceuticals media release, the company announced that the US Food & Drug Administration (FDA) has granted marketing approval to use SCENESSE (afamelanotide 16mg) for the treatment of EPP patients in the United States.
    • 08 Oct 2019 Results published in the Food and Drug Administration Media Release.
    • 03 Jun 2019 According to a Clinuvel Pharmaceuticals media release, New Drug Application of the SCENESSE (afamelanotide 16mg) is submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act.
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