Scenesse afamelanotide regulatory update

EMA's CHMP recommended approval of Scenesse afamelanotide from Clinuvel to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Scenesse was the first product to be included in an EMA pilot project to involve patients in CHMP's assessment of benefits and risks (see BioCentury, Sept 29). Scenesse has Orphan Drug designation in the U.S., EU, Australia and Switzerland for EPP. ...