2016 Announcements
Media release: FDA, CLINUVEL TO DISCUSS SCENESSE® AT PRE-NDA MEETING
11 October 2016
CLINUVEL PHARMACEUTICALS LTD today announced that it will meet with the US Food and Drug Administration (FDA) on 7 November to formally discuss lodging its new drug application (NDA) for the novel drug SCENESSE® (afamelanotide 16mg). The pre-NDA meeting will focus on finalising requirements for filing SCENESSE® with the FDA for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP).