Drug development news

Australian company Clinuvel have announced that their treatment known as SCENESSE® (Afamelanotide, 16mg) was approved as a treatment for the debilitating genetic disorder Erythropoietic Protoporphyria (EPP) in Europe. EPP is characterised by an extreme risk of severe burns (phototoxicity) of the skin. Many EPP sufferers can only venture out at night and can even suffer burns and scarring from bright light. 

  • Scenesse was also tried in clinical trials for vitiligo. Profs. Henry Lim, Mark Lebwohl and coauthors reported ( PubMed) results of multicenter Phase I clinical trials of Afamelanotide in combination with narrowband UVB. Authors noticed faster and better repigmentation in experimental group compared to the control group receiving only NB-UVB, yet this effect was limited to dark skin types (type IV-VI) but not for type III skin or lighter.

The new drug acts as an anti-oxidant and activates melanin in skin, which in turn increases pigmentation of the skin and provides barrier from harmful UV rays. The benefits are a decrease in light sensitivity, and a limited increase in time EPP patients may spend in daylight. The most common side effects are headache, nausea, nasopharyngitis, migraine, abdominal pain, fatigue, lethargy and somnolence.

Each 16mg implant costs around $6,200 and lasts 60 days.

Under current EMA approval, Scenesse will be closely monitored under a “pharmacovigilance” plan to ensure the treatment remains effective and there is no off-label usage. Despite not being currently approved for vitiligo, this drug may also be one of the treatment options for some vitiligo sufferers down the road.

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