EMA Acknowledges Clinuvel’s Novel Drug Filing in Europe in 2011
5/12/2011 9:38:35 AM
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it held a constructive Pre-Submission Meeting with the European Medicines Agency (EMA) on May 5. After reviewing the proposed content of the registration dossier for the novel drug afamelanotide (SCENESSE®), the EMA acknowledged that Clinuvel would meet all filing requirements. The EMA agreed with Clinuvel’s tentative dossier submission period of the last quarter of 2011 for the orphan designated disease erythropoietic protoporphyria (EPP).