Australian TGA approves Scenesse to prevent phototoxicity in adult patients with erythropoietic protoporphyria -Clinuvel Pharmaceuticals

Clinuvel Pharmaceuticals announced that the Australian Therapeutic Goods Administration (TGA) has approved the registration of its drug Scenesse (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). Scenesse is the first treatment approved for EPP patients in Australia. The TGA evaluated the Scenesse dossier under Section 25 of the Therapeutic Goods Act (1989) and notified Clinuvel in line with Section 25(3) of its decision to approve the drug’s registration on the Australian Register of Therapeutic Goods (ARTG). The notification completes a nine-month review by the TGA following validation of the Scenesse dossier.Scenesse will be registered in Australia for the indication “the prevention of phototoxicity in adult patients with EPP”. The drug will be available as a prescription medication in Australia, to be administered by trained and accredited healthcare professionals every two months. Clinuvel will implement a comprehensive training and accreditation program, ensuring that healthcare professionals are provided with information in line with the approval.