Benzinga | Dec 21, 2021 08:05AM EST

Zogenix Submits New Drug Application For FINTEPLA In Japan For The Treatment Of Epileptic Seizures Associated With Dravet Syndrome

Zogenix, a global biopharmaceutical company specializing in rare disease therapies, announced that it has submitted a New Drug Application (J-NDA) to the Japanese Ministry of Health, Labour & Welfare (MHLW) for the marketing approval of FINTEPLA(r) (fenfluramine) for the treatment of epileptic seizures associated with Dravet syndrome in Japan. FINTEPLA received Orphan Drug Designation from Japan's Ministry of Health, Labour & Welfare (MHLW) in August 2021.

"There remains a substantial unmet need in the Dravet syndrome treatment landscape globally, and Japan is no exception where patients continue to experience refractory seizures that negatively impact quality of life," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are committed to advancing FINTEPLA as a potential treatment option to ensure that patients in Japan living with this rare, highly refractory form of childhood-onset epilepsy have access to this therapy."

The submission is supported by the results of Study 3, a multi-national randomized, double-blind, placebo-controlled, Phase 3 study, of 143 children and young adults with Dravet syndrome, including trial participants from Japan, whose seizures were not adequately controlled by existing anti-epileptic drugs. Study 3 met its primary objective in demonstrating that patients in the FINTEPLA 0.7 mg/kg/day group achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group (p<0.0001). FINTEPLA was generally well-tolerated in this study, with adverse events consistent with those observed in previous Phase 3 studies, Study 1 and Study 2, and with the known safety profile of fenfluramine.

Zogenix retains responsibility for completing its global clinical development programs and seeking regulatory approval for FINTEPLA in Japan for Dravet syndrome and Lennox Gastaut syndrome. If approved in Japan, FINTEPLA will be commercialized in Japan through Zogenix's exclusive distribution agreement with Nippon Shinyaku, Co., Ltd., a leading Japanese pharmaceutical product developer and distributor.