With eye on winning over FDA in the wake of RTF, Zogenix publishes new Fintepla data
Battered by a refuse-to-file letter from the FDA in April, Zogenix has made strides to convince the FDA that its Dravet syndrome drug is worth approval. Last month, the regulator accepted its resubmitted application to market Fintepla, one half of the notorious axed prescription weight-loss cocktail fen–phen, for patients with the rare, severe form of childhood epilepsy.
Earlier this week, data from a Zogenix-funded 119-patient study led by researchers from UCSF, University of Leuven and other treatment centers showed that Fintepla, known chemically as fenfluramine, helped cut convulsive seizures by 62% versus placebo in patients with Dravet syndrome.
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