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: 09 Oct 2019
Price : $35 *
At a glance
- Drugs Afamelanotide (Primary)
- Indications Erythropoietic protoporphyria
- Focus Registrational; Therapeutic Use
- Sponsors Clinuvel Pharmaceuticals
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History