The FDA extended by three months the review period for Zogenix’s New Drug Application (NDA) for Fintepla (ZX008), an investigational anti-seizure therapy for patients with Dravet syndrome.
The agency now expects to provide a decision by June 25 on whether to approve Fintepla for the treatment of seizures associated with Dravet.
The extension will allow the FDA more time to review additional data Zogenix submitted in response to a request from the agency. “The FDA determined that the submission of this information constituted a major amendment to the NDA,” Zogenix said.
The company resubmitted the data in November 2019. The FDA gave the application priority review status, meaning it could take action within six months, instead of the standard 10 months.