2016 Announcements

FDA awards SCENESSE® Fast Track designation for treatment of EPP

05 July 2016

Executive summary:

  • FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPP
  • NDA filing allowed on a rolling basis
  • FDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment

Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has granted SCENESSE® (afamelanotide 16 mg) Fast Track designation for the treatment of erythropoietic protoporphyria (EPP). This designation recognises the severity of EPP and the unmet medical need of the disorder in the US. SCENESSE® is commercially available for EPP patients in Europe.

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