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)

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2016

At a glance

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

    • 18 Jul 2016 According to a Clinuvel Pharmaceuticals media release, FDA requested the company to submit data from this and other trials conducted between 2006 and 2013, as well as data from over 200 patients who received the drug during compassionate use and special access programs, for NDA approval (on January 2016). The FDA, after reviewing the data, has deemed Clinuvel's clinical data package satisfactory for submitting a New Drug Application (NDA) (as of 18 Jul 2016).
    • 06 Jul 2016 According to a Clinuvel media release, a pre-NDA meeting will take place shortly with the FDA to discuss the timing of the first filing of the complete scientific sections of the NDA dossier.
    • 06 Jul 2016 According to a Clinuvel media release, the US FDA has granted Fast Track Designation to afamelanotide (SCENESSE) enabling a New Drug Application (NDA) on a rolling basis for US regulatory assessment.
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