SCENESSE approved for EPP in Europe

Written by David Pascoe on October 27, 2014 in melanotan, Scenesse (Afamelanotide Implant 16mg) with 0 Comments

afamelanotide

Clinuvel have announced that their treatment known as SCENESSE (yes another product insisting on all caps) has been approved as a treatment for Erythropoietic Protoporphyria (EPP) in Europe.

SCENESSE has previously been granted Orphan Drug Designation in Europe, USA, Australia and Switzerland. Scenesse was approved for use in Italy in 2010.

Europe approves novel Australian drug developed for rare sun disease

Friday, 24 October 2014 20:00

The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval from the European Medicines Agency (EMA). SCENESSE (afamelanotide 16mg) treats the debilitating genetic disorder porphyria (EPP), or absolute intolerance to sunlight. The fear of lifelong burns requires EPP patients to lead an indoor, isolated existence avoiding any form of light.

SCENESSE is the first treatment ever to have been developed for EPP.

EPP is characterised by an extreme risk of severe burns (phototoxicity) of the skin resulting in intolerable pain, swelling, scarring and a state of distress. A severe reaction – triggered by exposure to light, particularly sunlight – may result in hospitalisation.

Since 2006 Australian company Clinuvel Pharmaceuticals has invented, developed and tested SCENESSE . The drug – the first approved from a new family of drugs known as melanocortins – acts as an anti-oxidant and activates melanin in skin, providing patients with a biological barrier between their skin and the various wavelengths of light triggering phototoxic reactions. Clinical trials in 350 adult EPP patients have shown the drug to be well tolerated, to reduce the incidence and severity of reactions, and to dramatically improve patients’ quality of life.

What about Rosacea?

Despite not being currently targeted as rosacea treatment, SCENESSE remains interesting for rosacea sufferers who identify exposure to the sun as a significant trigger for their symptoms.

Whilst the number of people who suffer from EPP is relatively few (say compared to rosacea) many more suffer from Vitiligo which may also soon be a condition treatable by SCENESSE.

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