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Dravet syndrome is a rare inherited childhood epilepsy syndrome characterized by refractic epilepsy and neurodevelopmental problems that begin in inflamm.
70%-80% of Patients with Dravet syndrome detected mutations in the voltage gated sodium ion channel α-1 sub-gene (SCN1A).
biopharmaceutical company Zogenix recently announced that the European Medicines Agency (EMA) Human Medicines Commission (CHMP) has recommended that FINTEPLA® marketing licenses be granted to treat seizures associated with Drafet syndrome.
expected the European Commission to make a final decision on the company's market authorization application (MAA) by the end of the year. Dr Stephen J. Farr, President and CEO of
Zogenix, said, "Six years ago, Belgian researchers realized that fenfluoramine had a different pharmacological effect than other anticonvulsant drugs, which can treat stubborn seizures of Dravet syndrome, so we started a rigorous FINTEPLA global development program."
Lieven Lagae, head of the Department of Paediatric Neurology at the University of Leuven in Belgium, said: "Reducing the frequency of seizures is the first and most important step in treating all children with Dravet syndrome, regardless of age.
Phase III studies of fenfluoramine have shown that fenfluoramine reduces the frequency of seizures in patients with Dravet syndrome."
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