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)
Phase of Trial: Phase III
Latest Information Update: 28 Feb 2018
At a glance
- Drugs Afamelanotide (Primary)
- Indications Erythropoietic protoporphyria
- Focus Registrational; Therapeutic Use
- Sponsors Clinuvel Pharmaceuticals
- 28 Feb 2018 According to a Clinuvel Pharmaceuticals media release, the Company is currently preparing to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA).
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History