Zogenix announced it has completed its rolling submission of a New Drug Application (NDA) to the US Food & Drug Administration (FDA) and submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Fintepla (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome.
The filings are based on data from two pivotal Phase III trials and an open-label extension study in Dravet syndrome, which demonstrated highly significant, safe and durable seizure reduction.
The studies found that children and young adults treated with the drug achieved a 54% greater reduction in mean monthly convulsive seizures, paired with a median longest seizure-free interval of 22 days, as opposed to 13 days for patients in the placebo group.
“Our concurrent submissions to the FDA and EMA are the culmination of four years’ effort for Zogenix, our investigators, and the families who participated in the ZX008 clinical trial program,” said Stephen Farr, president and chief executive executive of the firm.
He continued, “We are honoured to have partnered with such dedicated people to develop a potential new treatment for this rare and often catastrophic disease and look forward to working closely with the FDA and EMA during the review process.”
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.