ZGNX - Zogenix submits Fintepla application in Japan for Dravet syndrome

Zogenix (NASDAQ:ZGNX) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour & Welfare (MHLW) for the marketing approval of Fintepla (fenfluramine) for the treatment of epileptic seizures associated with Dravet syndrome. The submission is supported by the results of Phase 3 study of 143 children and young adults with Dravet syndrome, which met its primary objective. Dravet syndrome is a rare form of epilepsy that generally begins in infancy or early childhood and is marked by frequent treatment-resistant seizures, significant developmental, motor, and behavioural impairments, and an increased risk of sudden unexpected death. Fintepla received Orphan Drug Designation from Japan’s MHLW in August 2021.

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Zogenix submits Fintepla application in Japan for Dravet syndrome