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
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
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.
Forward Looking Statements
Senior Director, Corporate Communications
+1 (858) 449 9575 | firstname.lastname@example.org
+1 (646) 597-6987 | Andrew@lifesciadvisors.com
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, Inc.