Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application

A global pharmaceutical company developing rare disease therapies, today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome.

Upon its preliminary review, the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review.  In the letter, the FDA cited two reasons for the RTF decision: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA. The FDA has not requested or recommended additional clinical efficacy or safety studies.

The Company will seek immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.

"We remain highly confident in Fintepla’s clinical profile demonstrated in the Phase 3 program in Dravet syndrome and are committed to advancing the product candidate as a potential new treatment option for this and other rare and often catastrophic epileptic encephalopathies," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are fully committed to working with the FDA as quickly as possible to address the open issues and clarify the path to successfully re-filing our application."

Zogenix’s Marketing Authorization Application (MAA) for Fintepla for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency (EMA), and the Company anticipates an approvability decision could be reached by the EMA in the first quarter of 2020.

About Zogenix

Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company’s lead candidate, Fintepla® (ZX008, fenfluramine) has been accepted for review by the European Medicines Agency and is in development in Japan.

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