17 July 2016
Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP)
- FDA concludes initial review of datasets on SCENESSE® in EPP
- FDA deems datasets satisfactory for submission of New Drug Application
- Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure
- Clinuvel will request rolling review of NDA under Fast Track designation
- Clinuvel to request Priority Review to shorten review from 10 to 6 months
Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has concluded an initial review of Clinuvel’s clinical data package for its drug SCENESSE® (afamelanotide 16mg) in patients with the orphan (rare) genetic disorder erythropoietic protoporphyria (EPP). The FDA has deemed Clinuvel’s clinical data package satisfactory for submitting a New Drug Application (NDA).