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Find Clinical Drug Pipeline Developments & Deals by Zogenix
FINTEPLA® (fenfluramine) oral solution is a prescription medication approved in the U.S. and Europe, and under regulatory review in Japan, for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
FINTEPLA (fenfluramine) is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome and is in development in Japan for the treatment of seizures associated with Dravet syndrome.
The transaction will broaden and build upon UCB's role as a leader in rare forms of epilepsy after adding FINTEPLA® to UCB's existing product line and complementing existing medicines and expanding clinical development pipeline of epilepsy.
The submission is based on the results of Phase 3, which met its primary objective in demonstrating that patients in the FINTEPLA (Fenfluramine) achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group.
sNDA is supported by Phase 3 Study 1601 for FINTEPLA® (fenfluramine) for treatment of seizures associated with Lennox-Gastaut Syndrome to FDA. FINTEPLA is approved by the FDA and European Commission for treatment of seizures associated with Dravet syndrome.
Zogenix plans to submit a new drug application (J-NDA) for FINTEPLA in Japan for the treatment of seizures associated with Dravet syndrome by year end.
Across studies, FINTEPLA has been generally well-tolerated, with no observed cases of pulmonary arterial hypertension (PAH) or valvular heart disease (VHD). The most common adverse events were reported as decreased appetite, fatigue, diarrhea, and pyrexia.
The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.
More LGS study patients treated with FINTEPLA (fenfluramine) showed improvement in each of the BRIEF 2 indexes that have been used to assess behavior, emotion, and cognitive function in intractable epilepsy and other developmental conditions.
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