The U.S. Food & Drug Administration (FDA) has issued a Refusal to File (RTF) letter to Zogenix, Inc. for the rolling submission of their New Drug Application (NDA) for Fintepla (ZX008, low-dose fenfluramine). The FDA cited two deficiencies and is asking for additional non-clinical animal study data and re-submission of an incorrect dataset submitted with their submission. Zogenix will be meeting with the FDA in coming months and working closely with them to address the FDA’s requests and resubmit their NDA.
Patients currently enrolled in clinical trial will continue to receive Fintepla and Zogenix will still be offering an Expanded Access Program for patients that qualify through selected sites, as planned
Chief Medical Officer, Brad Galer, M.D. issued a letter addressing the patient communities they serve which can be found here.