PDUFA target action date extended by three months to June 25, 2020
EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (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.
Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include the timing and results of any decision regarding the NDA from FDA. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the FDA may not agree with the Company’s interpretation of results from its clinical trials; the FDA may request additional data in connection with its review of the NDA; the potential for the FDA to further delay the PDUFA target action date related to the Dravet syndrome NDA due to the FDA's internal resource constraints or other reasons; additional data from Zogenix’s ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Senior Director, Corporate Communications
+1 (510) 788-8732 | firstname.lastname@example.org
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | email@example.com