Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for FINTEPLA® for the Treatment of Dravet Syndrome
“The FDA’s acceptance for filing of the NDA under Priority Review for our investigational product, FINTEPLA, represents a significant milestone in its development,” said
Priority review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
In its NDA filing acceptance letter, the
The NDA 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 is also investigating FINTEPLA in Lennox-Gastaut syndrome, another rare, severe childhood-onset epileptic syndrome, for which a Phase 3 trial is ongoing, with top-line data results anticipated in the first quarter of 2020.
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 has two late-stage development programs underway: FINTEPLA® (fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies. Additionally,
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 the
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Source: Zogenix, Inc