Trial Profile
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)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Oct 2021
Price :
$35
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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.