Zogenix Submits New Drug Applications

Zogenix, Inc. announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) and submitted a Marketing Authorization Application (MMA) to the European Medicines Agency (EMA) for FINTEPLA (ZX008, low-dose fenfluramine). Both applications are based on data from two pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.

Read the full news release here.