February 11, 2019

Zogenix Submits New Drug Application to FDA and Marketing Authorization Application to European Medicines Agency for FINTEPLA® for the Treatment of Dravet Syndrome

Zogenix, Inc. announced it 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 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.

Related News

February 14, 2024

Fintepla Safely Reduces Seizures in Children Younger than 2, Study Finds

Treatment with Fintepla (fenfluramine) appeared to be reasonably safe and lower seizure frequency in five children with Dravet syndrome who started on the therapy before they were two years old.

January 12, 2024

Seizures Identified as Potential Cause of Sudden Unexplained Deaths in Children

“These findings show that seizures are much more common than patients’ medical histories suggest, and that further research is needed to determine if seizures are frequent occurrences in sleep-related deaths in toddlers, and potentially in infants, older children, and adults,”

December 14, 2023

The Mozart Effect Myth: Listening to Music Does Not Help Against Epilepsy

“Mozart’s music is beautiful, but unfortunately, we cannot expect relief from epilepsy symptoms from it”, conclude the researchers.