ZGNX - EMA backs Zogenix's marketing application for Fintepla oral solution in Dravet syndrome

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending the marketing authorization of Zogenix's (ZGNX) FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare infant and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older.The European Commission is expected to make a final decision on the marketing application by the year end. The product is expected to be made available under a controlled access program.ZGNX +8% premarket.

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EMA backs Zogenix's marketing application for Fintepla oral solution in Dravet syndrome