Posted by Michael Wonder on 06 Feb 2018
Zogenix announces receipt of FDA breakthrough therapy designation for ZX008 in Dravet syndrome
6 February 2018 - Designation based on positive results from Study 1, the first pivotal Phase 3 trial of ZX008.
Zogenix today announced that the U.S. FDA has granted breakthrough therapy designation for its investigational product, ZX008 (low-dose fenfluramine), for the treatment of seizures associated with Dravet syndrome.
FDA breakthrough therapy designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint. FDA breakthrough therapy designation for ZX008 is based on the results from Study 1, Zogenix’s first global Phase 3 trial of ZX008, which met the primary efficacy endpoint, as well as all pre-specified key secondary efficacy endpoints.
