FDA approves Banzel to treat seizures associated with LGS in pediatric patients

FDA has approved rufinamide (Banzel, Eisai) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients.

LGS is a severe form of epilepsy that begins in childhood, usually before aged 4 years. LGS is characterized by multiple types of seizures including tonic, atonic, atypical absence, and myoclonic seizures. This condition may be caused by brain malformations, severe head injury, central nervous system infection, and inherited degenerative or metabolic conditions. Most children with LGS experience some degree of impaired intellectual functioning along with developmental delays and behavioral disturbances.

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Banzel is a triazole derivative that is unrelated to other marketed anticonvulsants. Its exact mechanism is unknown however, it is thought to prolong the inactive state of sodium channels which limits repetitive firing of action potentials which produces its anticonvulsant effects. It was first approved by FDA in 2008 to treat seizures associated with LGS in children aged 4 years and older and adults.

"The approval of Banzel for pediatric patients, one to four years of age, represents an important milestone, as it may help to address an unmet need of younger patients with Lennox-Gastaut Syndrome," said Lynn Kramer, Chief Clinical Officer (ECL) and president, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai. 

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FDA's approval is based on a clinical trial which compared adjunctive Banzel to the adjunctive treatment with an antiepileptic drug of the investigator’s choosing in pediatric patients with inadequately controlled LGS.  The study demonstrated that the pharmacokinetic and safety profiles in patients aged 1  to 4 years are consistent with those seen in aged 4 years and above.

The adverse reaction profile in patients aged 1 to 4 years old was similar to that observed in adults and pediatric patients 4 years of age or older. The most common side effects included vomiting, drowsiness, bronchitis, constipation, cough, decreased appetite, and rash. Banzel is contraindicated in patients with Familial Short QT syndrome. 

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