In April, the FDA issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride). The drug was developed to treat seizures associated with Dravet syndrome, a rare form of epilepsy characterized by frequent and prolonged seizures.
The company at the time indicated the application, which was submitted in February, was not “sufficiently complete to permit a substantive review.” The FDA had two concerns, the first over non-clinical studies that were not submitted over chronic administration of the drug, and what Zogenix indicated as an incorrect version of a clinical dataset.
Now, the company announced that after its Type A meeting with the FDA on May 30, it plans to resubmit its NDA for Fintepla. Based on the meeting, the company will resubmit the NDA without the inclusion of the new chronic toxicity studies requested in the original RTF letter. In terms of the second issue, Zongenix ran a root cause analysis to explain the incorrect clinical dataset originally submitted and discussed that analysis with the agency.
“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 re-submission,” stated Stephen J. Farr, president and chief executive officer of Zogenix. “We now have the clarity required to successfully resubmit our Fintepla NDA, which we will anticipate will occur in the third quarter.”