The Food and Drug Administration (FDA) has agreed that the new drug application (NDA) may be resubmitted for low-dose fenfluramine (Fintepla, previously known as ZX008; Zogenix, Emeryville, CA) without additional studies. Low-dose fenfluramine is investigational and being studied for treatment of seizures associated with Dravet syndrome.
The FDA had generated a refusal-to-file letter for low-dose fenfluramine based on the absence of certain nonclinical studies and an incorrect version of a clinical dataset. After a type A meeting between the drug developer, Zogenix, and the FDA, the FDA has agreed to reconsider the NDA without inclusion of new chronic toxicity studies that had been requested, considering that such studies are already available and will be included in the new NDA. With regard to the incorrect data set, Zogenix conducted and shared a root cause analysis with the FDA explaining how the incorrect clinical dataset was submitted.
The NDA is expected to be resubmitted with the chronic toxicity studies and correct datasets in the third quarter of 2019.
Stephen J. Farr, PhD, president and chief executive officer of Zogenix said, “We are very pleased with the outcome of our meeting with the FDA and appreciate their thoughtful approach in considering the totality of the data from our drug development program, along with additional clinical and non-clinical literature that will be referenced in our resubmission.”
Arnold M. Salazar; Amanda M. Leisgang; Andrew A. Ortiz; and Jefferson W. Kinney, PhD
Chengyuan Wu, MD, MSBmE
Hans D. Katzberg, MD, MSc, FRCPC; and Hamid Sadeghian, MD, FRCPC