Zogenix, Inc. anticipates that they will be resubmitting their New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the third quarter, 2019 without additional chronic toxicity studies for Fintepla (ZX008, low dose fenfluramine). In April, the FDA issued a Refusal to File (RTF) letter to Zogenix citing two deficiencies. They asked for additional non-clinical animal study data and re-submission of an incorrect dataset submitted with their submission.
In May the FDA held a Type A meeting with Zogenix to review the two issues identified in the RTF. The FDA agreed to Zogenix’s plan to resubmit the NDA for Fintepla without inclusion of the new toxicity studies requested in the RTF. They also agreed with the company’s plan for resubmission of the incorrect datasets.
Read the full news release here.