2019 Announcements
TGA Priority Registration Pathway for SCENESSE
CLINUVEL PHARMACEUTICALS LTD today announced that the Australian Therapeutic Goods Administration (TGA) has granted SCENESSE® (afamelanotide 16 mg) the right to be filed under the priority registration process. This establishes a target scientific evaluation timeframe of 150 working days, calculated from the first day the scientific dossier is accepted. SCENESSE® will be lodged for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).