FDA accepts SCENESSE® clinical data package for NDA submission

17 July 2016

Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP)

Executive summary:

  • 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).

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