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Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH)

Afamelanotide

Approvedaka Scenesse, Melanotan I, NDP-MSH, CUV1647, [Nle4-D-Phe7]-alpha-MSH

Afamelanotide is a linear analogue of alpha-melanocyte-stimulating hormone developed by the Australian company Clinuvel. By activating the melanocortin-1 receptor it increases skin eumelanin, providing photoprotection. It is approved for erythropoietic protoporphyria on the basis of Phase 3 randomized trials and is administered as a controlled-release implant by trained physicians.

Mechanism

In plain terms, afamelanotide increases the skin's own protective brown pigment so that people with an extreme light-sensitivity disorder can tolerate more light without pain. Technically, it is a potent, longer-acting analogue of alpha-MSH ([Nle4-D-Phe7]-alpha-MSH) that agonises the melanocortin-1 receptor (MC1R) on melanocytes, stimulating eumelanin synthesis; eumelanin absorbs and scatters light and helps quench reactive oxygen species, reducing phototoxic reactions in erythropoietic protoporphyria.

Regulatory Status by Region

  • United States (FDA)Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician.
  • Australia (TGA)Approved by the TGA and registered on the Australian Register of Therapeutic Goods (ARTG) in November 2020 as Scenesse (afamelanotide) implant for the prevention of phototoxicity in adults with erythropoietic protoporphyria; sponsored by the Australian company Clinuvel Pharmaceuticals.
  • European Union (EMA)Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
  • WADANot specifically named on the WADA Prohibited List; as an approved medicine used for a rare photodermatosis it does not fall within a listed prohibited class.

Key Studies

  • Afamelanotide for Erythropoietic Protoporphyria (two Phase 3 randomized controlled trials) (Langendonk JG, et al. N Engl J Med. 2015.)
  • FDA approval of SCENESSE (afamelanotide) to increase pain-free light exposure in adults with erythropoietic protoporphyria (U.S. Food and Drug Administration, approved October 2019.)
  • Scenesse (afamelanotide) marketing authorisation for prevention of phototoxicity in erythropoietic protoporphyria (European Medicines Agency, authorised 2014.)

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