CLINUVEL Newsletter – July 2018
27 July 2018
On 25 June 2018 CLINUVEL announced its New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) for adult erythropoietic protoporphyria (EPP) patients had been submitted to the US Food and Drug Administration (FDA). It has been imperative for our teams to thoroughly prepare the scientific write-up and analyses of the use of afamelanotide 16mg while taking into consideration the learnings from our submission to the European Medicines Agency (EMA) back in 2012. The ensemble of data managers, statisticians, regulatory experts, pharmacovigilance and clinical managers – without short changing the back-office and supporting staff – have worked tirelessly towards this landmark submission.