Scenesse afamelanotide regulatory update

In December, the European Commission approved under exceptional conditions Scenesse afamelanotide from Clinuvel to prevent phototoxicity in patients with erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Under the approval, Clinuvel will establish a postmarket program to monitor safety and efficacy in patients, conduct a Phase IV pharmacokinetic study in 12 patients and submit periodic safety reports to EMA. ...