Zogenix Inc. received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development program for the Company’s investigational product, ZX008, as a treatment of seizures associated with Dravet syndrome, a rare and catastrophic form of childhood epilepsy.
“The FDA granting Fast Track designation provides important support as we advance the development program for ZX008 in Dravet syndrome towards a potential approval as quickly as possible,” said Stephen Farr, Ph.D., Chief Executive Officer of Zogenix.
The FDA's Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address unmet medical needs.
Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with the FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.
