Orphan drug designation formally granted for Idogen in Europe
Idogen AB (“Idogen”) today announces that the European Commission formally has granted Idogen’s orphan drug designation for the treatment of patients with hemophilia A in Europe. An orphan drug designation provides several important advantages for Idogen – the product receives market exclusivity in the EU for ten years following marketing authorization and Idogen will benefit from free scientific advice and lower costs for regulatory applications for market introduction.In December 2016 the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) reached a positive opinion