Zogenix Prepares for Second Shot at Seizure Drug Submission

Back in April 2019, Emeryville, California-based Zogenix received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome. There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.