CLINUVEL brief on European commercialisation
19 February 2016
CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercialisation of its novel drug SCENESSE® (afamelanotide 16mg) in adult patients with erythropoietic protoporphyria (EPP) in Europe.
CLINUVEL has been working towards finalising distribution infrastructure, with a focus on a Risk Management Plan (RMP) and pharmacovigilance in accordance to EU legislation to undertake the long term follow up of EPP patients receiving SCENESSE®. Patients will be treated in accordance with a Post-Authorisation Safety (PASS) Protocol.