Posted by Michael Wonder on 26 Jun 2018
Historic new drug application for the use of Scenesse in rare metabolic disorder EPP
25 June 2018 - Priority review requested to FDA.
Clinuvel Pharmaceuticals today announced that it has completed the submission of a new drug application for its drug Scenesse (afamelanotide 16 mg) as the first proposed therapy for patients with the rare metabolic disorder erythropoietic protoporphyria (EPP) in the United States.
An approved application will allow Clinuvel to make Scenesse available to adult EPP patients in the US as a first-line therapy.
