2018 Announcements
CLINUVEL COMPLETES SCENESSE® FDA FILING
25 June 2018
EXECUTIVE SUMMARY
- First NDA for SCENESSE® (afamelanotide 16mg) in the United States
- First-line therapy proposed as systemic photoprotection for EPP patients
- Submission of data from five clinical trials in EPP, pooled data, Compassionate Use, Special Access Schemes, and real-world experience from European use
- Nearly 6,700 afamelanotide doses administered to more than 800 patients
- Priority Review requested to FDA
CLINUVEL PHARMACEUTICALS LTD today announced that it has completed the submission of a New Drug Application (NDA) for its drug SCENESSE® (afamelanotide 16 mg) as the first proposed therapy for patients with the rare metabolic disorder erythropoietic protoporphyria (EPP) in the United States. An approved NDA will allow CLINUVEL to make SCENESSE® available to adult EPP patients in the US as a first-line therapy.