2018 Announcements
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