According to BioSpace, a marketing authorisation application (MAA) for afamelanotide (Scenesse®), a first-in-class orphan drug intended as a prophylactic treatment in adult patients with erythropoietic protoporphyria (EPP), has been submitted to the European Medicines Agency (EMA). 

EPP is a rare genetic disease found mainly in fair-skinned people that is characterised by severe phototoxicity of the skin resulting in intolerable pain, swelling and scarring, usually of exposed areas such as the face, hands and feet. Symptoms can vary from mild to extreme lasting pain requiring hospitalisation.  Presently there is no known effective treatment for EPP, which affects approximately 10,000 people globally, an estimated 4,000 in Europe.

Afamelanotide is a linear peptide which activates eumelanin in skin, which protects skin from light and UV radiation (photoprotection). Scenesse® is administered underneath the skin as a dissolvable implant, approximately the size of a grain of rice, which activates eumelanin for a period of two months.