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Zogenix Submits New Drug Application to U.S. Food & Drug Administration and Marketing Authorization Application to European Medicines Agency for FINTEPLA® for the Treatment of Dravet Syndrome

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Tuesday, February 12, 2019

EMERYVILLE, Calif.- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for FINTEPLA (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome. Dravet syndrome is an intractable and difficult-to-treat epilepsy that begins in infancy and is associated with frequent, severe, and potentially life-threatening seizures, developmental delay, and cognitive impairment.i,ii

Both applications are based on data from two 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.

“Our concurrent submissions to the FDA and EMA are the culmination of four years’ effort for Zogenix, our investigators, and the families who participated in the ZX008 clinical trial program,” said Stephen J. Farr, President and Chief Executive Officer of Zogenix. “We are honored to have partnered with such dedicated people to develop a potential new treatment for this rare and often catastrophic disease and look forward to working closely with the FDA and EMA during the review process.”

Zogenix is also investigating FINTEPLA in Lennox-Gastaut syndrome, another rare childhood-onset epilepsy, for which a Phase 3 trial is ongoing.

About Dravet Syndrome
Dravet syndrome is a rare form of intractable (treatment-resistant) epilepsy that begins in infancy and is associated with frequent, severe, and potentially life-threatening seizures, developmental delay, cognitive impairment, and an elevated risk of sudden unexplained death in epilepsy (SUDEP).i,ii Early estimates on the incidence of Dravet syndrome ranged from one in 20,000 to one in 40,000; however more recent research suggests the incidence may be as frequent as one in 15,700.iii The disease also has an impact on the entire family, often resulting in substantial financial, physical, psychosocial and emotional burdens.

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. For more information, visit www.zogenix.com.

CONTACTS:

Zogenix
Melinda Baker
Senior Director, Corporate Communications
media@zogenix.com

Media
Rachel Lipsitz
Public Relations, Syneos Health
+1 (858) 449 9575 | rachel.lipsitz@syneoshealth.com

Investors
Andrew McDonald
Founding Partner, LifeSci Advisors LLC
+1 (646) 597-6987 | Andrew@lifesciadvisors.com

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iNational Organization for Rare Disorders. Dravet syndrome. https://rarediseases.org/rare-diseases/dravet-syndrome-spectrum.
ii Wirrell EC, Laux L, Donner E, et al. Optimizing the diagnosis and management of Dravet syndrome: Recommendations from a North American consensus panel. Pediatr Neural. 2017; 68: 18-34.
iii Wu YW, Sullivan J, McDaniel S, et al. Incidence of Dravet Syndrome in a US Population. Pediatrics. 2015; 3.

Source: Zogenix
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