Zogenix (ZGNX) Announces FDA Extension of Review Period for FINTEPLA in Dravet Syndrome

Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act (PDUFA) target action date has been extended by three months to June 25, 2020.

The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the PDUFA goal date by three months.

“We remain very confident in the data supporting our NDA submission, and look forward to continuing discussions with the FDA during the review process,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We are committed to bringing this investigational therapy forward to help meet the needs of patients and families with Dravet syndrome.”

The NDA for FINTEPLA was originally accepted for filing in November 2019 under the FDA’s Priority Review program with a six-month review period, and is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.

Zogenix will be hosting its previously announced corporate update conference call and webcast on Monday, March 2, 2020, at 4:30 PM Eastern Time.

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