2016 Announcements
CLINUVEL agrees with FDA on New Drug Application timelines
8 November 2016
CLINUVEL today announced that it met on 7 November with the US Food and Drug Administration’s (FDA’s) Division of Dermatology and Dental Products (DDDP) to discuss the content and format of a new drug application (NDA) submission as part of the US regulatory pathway for CLINUVEL’s medicinal product SCENESSE® (afamelanotide 16mg). The pharmaceutical product has been developed for the treatment of erythropoietic protoporphyria (EPP)1, a rare genetic enzymatic disorder causing lifelong absolute light intolerance. The pre-NDA meeting allowed both parties to discuss expectations on timelines and the sequence of submissions of the NDA modules.