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)
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
- 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).
- 02 Jul 2015 Combined analysis of this (CUV039) and CUV029 pivotal trials was published in New England Journal of Medicine as per a Clinuvel Pharmaceuticals media release.
- 17 Apr 2014 New trial record