Clinuvel drug approved in Europe for rare sun disorder
Clinuvel Pharmaceuticals Ltd has announced that its drug SCENESSE® (afamelanotide 16mg) has received its first approval from the European Medicines Agency (EMA) to treat a disease caused by exposure to sunlight. The EMA’s Committee for Medicinal Products for Human Use (CHMP) voted in favour of marketing authorisation for SCENESSE® under exceptional circumstances for the rare genetic disorder erythropoietic protoporphyria (EPP).
SCENESSE® is the first treatment ever to have been developed for EPP, a debilitating disorder which is clinically regarded as extreme intolerance to light and UV (phototoxicity). These patients suffer from intolerable pain, swelling, scarring and a state of distress which may result in hospitalisation.
The first of five trials of SCENESSE® for EPP started in 2006, with Clinuvel pioneering the development of a new formulation of the drug, and designing and executing an entirely novel clinical program for EPP. SCENESSE® is the first drug developed by an Australian company and taken from novel molecule to marketing authorisation for a previously untreated disease.
“Today’s EMA outcome is a landmark achievement by Clinuvel and all those who worked with this program for nearly a decade,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “My first thoughts go out to the EPP patients and families who have been asking us for the release of the drug for many years.
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