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Scenesse
Published
Product name
Scenesse
Active ingredient
Afamelanotide acetate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Scenesse (afamelanotide) was approved for the following therapeutic use:
Scenesse is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
How this medicine works
Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1-R). It acts with four fold greater potency than α-MSH in vitro and, due to increased resistance to proteolysis, has a longer duration of action in vivo.Activation of the MC1-R receptor by afamelanotide stimulates the synthesis of eumelanin in melanocytes.Eumelanin contributes to photoprotection through different mechanisms including: strong broadband absorption of ultraviolet (UV) and visible light, where eumelanin acts as a filter antioxidant activity through scavenging of free radicals; and inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Scenesse was considered favourable for the therapeutic use approved.
Sponsor