CLINUVEL REGULATORY UPDATE

14 May 2018

CLINUVEL PHARMACEUTICALS LTD  today provided an update on its global programs to facilitate access to treatment for patients with the ultra-rare genetic disorder erythropoietic protoporphyria (EPP):

  • European Annual and Periodic Reports show positive benefit-risk and safety profile maintained
  • SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients)
  • >99% treatment compliance rate in European EPP population maintained
  • >85% of European patients on treatment consented to inclusion in disease registry
  • Confirmation that no off-label use of SCENESSE® has taken place
  • Individual Swiss patients have received >50 SCENESSE® implants over 12 years of treatment
  • EU data reviewed by EMA support US New Drug Application, expected to be filed with FDA before 1 July 2018 

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