SCENESSE (Clinuvel Pharmaceuticals Ltd)

Product name

SCENESSE

Date registered

18 November 2020

Evaluation commenced

31 January 2020

Decision date

26 October 2020

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.