Scenesse recommended for rare disease by EMA/CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization under exceptional circumstances for Scenesse (afamelanotide) for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP), a rare genetic disease which causes intolerance to light.

Scenesse is the first medicine for patients with this condition. It has been developed by Australian company Clinuvel Pharmaceuticals (ASX: CUV), which is currently the subject of a  takeover transaction by the USA’s Retrophin (Nasdaq: RTRX).

EPP affects fewer than 10,000 people in the European Union. After exposure to sunlight, patients with EPP feel a stinging pain in sun-exposed skin. Prolonged exposure to sunlight can lead to an incapacitating pain, often followed by redness and swelling of the skin. Patients with EPP are often not able to lead normal lives, because they cannot spend time outdoors. Scenesse acts by stimulating the production of a pigment called eumelanin, which naturally protects the skin against phototoxic reactions caused by sunlight.