SCENESSE (Clinuvel Pharmaceuticals Ltd)
Product name
SCENESSE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
144 working days (150)
Active ingredients
afamelanotide acetate
Registration type
NCE/NBE
Indication
SCENESSE (implant) is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.