Health Canada extends SCENESSE® review for CLINUVEL's EPP treatment

CLINUVEL announced that Health Canada has requested additional review time and information to complete its evaluation of SCENESSE® (afamelanotide) for adult patients with erythropoietic protoporphyria (EPP). The New Drug Submission (NDS) was accepted for evaluation in December 2024, and the review window is now expected to extend into 2026.

Dr. Dennis Wright, CLINUVEL's chief scientific officer, expressed surprise at the delay, noting the dossier has supported marketing authorisations in the U.S.A., Australia, and Europe. Canadian patients currently receiving SCENESSE® through the Special Access Program will remain unaffected.

SCENESSE® is the only EPP treatment approved by the European Medicines Agency and U.S. Food and Drug Administration, with approximately 19,500 doses administered to adult and paediatric patients. Clinical evidence demonstrates it provides year-round photoprotective treatment for EPP patients.