Fintepla filed with FDA and MAA for Dravet syndrome.- Zogenix

Zogenix has completed its rolling submission of a New Drug Application (NDA) to the FDA and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Fintepla (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome. Dravet syndrome is an intractable and difficult-to-treat epilepsy that begins in infancy and is associated with frequent, severe, and potentially life-threatening seizures, developmental delay, and cognitive impairment. Both applications are based on data from two pivotal Phase III 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.

Comment: Zogenix is also investigating Fintepla in Lennox-Gastaut syndrome, another rare childhood-onset epilepsy, for which a Phase III trial is ongoing.