Posted by Michael Wonder on 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the U.S. FDA and submitted a marketing authorisation application to the EMA for Fintepla (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome.
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.
