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Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.
Zogenix, a global pharmaceutical company, has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency for FINTEPLA.
FINTEPLA (ZX008, low-dose fenfluramine hydrochloride) is being evaluated for the treatment of seizures that are associated with Dravet syndrome-an intractable and difficult-to-treat form of epilepsy. Both submissions will be assessed based on the data from two Phase III trials and an interim analysis from an ongoing study.
“Our concurrent submissions to 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 J. Farr, president and chief executive officer of Zogenix in a press release. “We are honored 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 FDA and EMA during the review process.”
FINTEPLA already has orphan drug designation in the US and Europe and has received fast track and breakthrough therapy designation in the US for the treatment of Dravet syndrome. The company is also investigating the use of FINTEPLA in Lennox-Gastaut syndrome.