Afamelanotide

(Scenesse®)

Afamelanotide

Drug updated on 4/18/2024

Dosage FormImplant (subcutaneous; 16 mg)
Drug ClassMelanocortin receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

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Summary
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  • Afamelanotide (Scenesse) is indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
  • The information was derived strictly from one systematic review/meta-analysis study.
  • In comparison to other treatments, afamelanotide showed a moderate positive effect in reducing skin photosensitivity in EPP or XLP patients. This treatment was compared against various modalities ranging from sunscreen application to oral treatments with vitamins or antioxidants and more invasive procedures like erythrocyte transfusion.
  • Other treatments such as the use of organic sunscreens, beta-carotene, cysteine, N-acetylcysteine, vitamin C, and warfarin showed no effect on skin photosensitivity according to controlled trials mentioned within the reviewed study.
  • Safety data for afamelanotide were compiled by regulatory agencies including the European Medicines Agency and United States Food and Drug Administration; however, specific details comparing its safety profile against other treatments were not explicitly discussed within this particular study.
  • Challenges highlighted include variability in experienced photosensitivity due to factors such as weather conditions, exposure patterns, and individual pigmentation which can affect the evaluation of treatment effects for EPP or XLP.

Product Monograph / Prescribing Information

Document TitleYearSource
Scenesse (afamelanotide) Prescribing Information.2020Clinuvel Inc., Burlingame, CA

Systematic Reviews / Meta-Analyses