Product Dossier
SCENESSE
Product Dossier for SCENESSE (afamelanotide acetate, Clinuvel Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Clinuvel Pharmaceuticals
- Active ingredient: afamelanotide acetate
- Therapeutic area: Rare Disease
- Same area: ORKAMBI
- Same area: BYLVAY
What it is
Scenesse is an afamelanotide 16 mg implant supplied as a vial.
Approved indications
— Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Key safety warnings
Nonclinical studies demonstrated the drug's melanogenic and photoprotective activity without significant toxicological concerns at therapeutic doses.
Regulatory history
Scenesse was approved by the TGA on 22 October 2020 for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The product received priority review and orphan drug designation. The product was first listed on the ARTG on 18 November 2020.