Zogenix Inc. said it resubmitted an application for epilepsy medicine Fintepla with the U.S. Food and Drug Administration.
The regulator had previously rejected the Emeryville, Calif.-based pharmaceutical company's new drug application, or NDA, over grounds that it contained insufficient and incorrect information. The drug's breakthrough-therapy designation was also rescinded.
In May, Zogenix was informed that it could resubmit its application without conducting a study originally requested by the FDA but would have to provide an analysis explaining why the incorrect clinical data was included in the previous NDA.
Fintepla, also known as fenfluramine, is a treatment candidate for seizures associated with Dravet syndrome, a rare form of epilepsy that begins in infancy.
The recent NDA is based on data from two late-stage studies in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which includes 232 patients treated for up to 24 months.
Zogenix is also investigating the drug in Lennox-Gastaut syndrome, another rare childhood-onset epilepsy, for which a phase 3 trial is underway.
