Posted by Michael Wonder on 25 Nov 2019
Zogenix announces FDA acceptance for filing of new drug application and priority review for Fintelpa for the treatment of Dravet syndrome
25 November 2019 - NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met the primary and all key secondary endpoints, and an interim analysis from an ongoing open-label extension study.
Zogenix today announced that the U.S. FDA has accepted for filing the Company’s new drug application for Fintelpa (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome.
The FDA granted priority review for the NDA for Fintelpa, which provides for a six-month review from the date of receipt, and assigned a Prescription Drug User Fee Act target action date of 25 March 2020.
