Clinuvel Pharmaceuticals Ltd announced today that the European Commission has ratified the recommendation of the European Medicines Agency (EMA), granting marketing approval under exceptional circumstances to Clinuvel’s breakthrough drug Scenesse (afamelanotide 16mg). 

Clinuvel is now allowed to market Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) across the 31 EMA countries. EPP is defined as the most severe clinical form of light and sunlight intolerance, often described as anaphylaxis to indoor and outdoor light sources. EPP patients are characterised by a lifelong fear of light, leading to a reclusive existence starved of daylight.

“Our objective has long been to provide EPP patients who are chronically deprived of light with a meaningful therapy to enable them to lead a normal existence free of impediment or psychological encumbrance,” Clinuvel’s CEO, Dr Philippe Wolgen said.  “Now the Clinuvel teams will focus on accelerating distribution of Scenesse while continuing to reach agreements with individual and collective insurers to provide national coding for a completely new pharmaceutical treatment.”

For more details, go to: http://www.clinuvel.com/en/investors/news-publications/announcements/2014-announcements/european-commission-approves-scenesse®