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A Phase III, Multicentre, Double-Blind, Randomized, 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, Randomized, 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: 20 Sep 2022

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At a glance

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

    • 05 Sep 2022 According to a Clinuvel Pharmaceuticals media release, the company has submitted a formal application to the European Medicines Agency (EMA) to expand the approved indication for SCENESSE (afamelanotide 16mg) to include the treatment of adolescent (aged 12 years and older) erythropoietic protoporphyria (EPP) patients.
    • 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.
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