Posted by Michael Wonder on 18 Jul 2016
FDA accepts Scenesse clinical data package for NDA submission
18 July 2016 - Clinuvel prepares new drug application for the treatment of erythropoietic protoporphyria.
Clinuvel Pharmaceuticals today announced that the US FDA has concluded an initial review of Clinuvel’s clinical data package for its drug Scenesse (afamelanotide 16 mg) in patients with the orphan (rare) genetic disorder erythropoietic protoporphyria. The FDA has deemed Clinuvel’s clinical data package satisfactory for submitting a new drug application.
