Clinuvel/FDA To Discuss NDA For Phototoxicity Drug Scenesse
This article was originally published in Scrip
Executive Summary
The Australian company Clinuvel Pharmaceuticals is to meet the US Food and Drug Administration in late September to discuss the NDA filing requirements for its orphan drug Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP), a rare genetic disorder characterized by an absolute intolerance to light.