FDA Approves BANZEL As Adjunctive Treatment For Severe Epilepsy Disorder
Eisai Corporation of North America announced today that the U.S. Food and Drug Administration (FDA) approved BANZEL (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. One of the most severe forms of childhood epilepsy, LGS is characterized by multiple and frequent seizures. LGS accounts for 1 to 4 percent of all childhood epilepsy cases; approximately 300,000 children under the age of 14 in the U.S. have epilepsy. Eisai received a complete response letter for BANZEL as an adjunctive treatment for partial-onset seizures with and without secondary generalization in adults and adolescents 12 years of age and older. BANZEL for LGS will be available to the public in January 2009.
A double-blind, placebo-controlled pivotal study of LGS patients treated with BANZEL as adjunctive therapy showed a 42.5 percent median reduction in frequency of drop attacks, seizures that cause a person to lose consciousness and fall to the ground, compared with a 1.4 percent median increase for placebo-treated patients. Drop attacks are a primary cause of injury in LGS patients.
"People living with LGS need more treatment options," said Tracy Glauser, MD, Director, Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center, Ohio, and lead investigator in a clinical trial for BANZEL. "What's exciting about this study is that BANZEL was effective and generally well tolerated in children with LGS whose seizures were previously uncontrolled on other multiple antiepileptic medications."
LGS is a disease that is devastating to the lives of patients and caregivers. Children usually experience the onset of LGS between the ages of 1 and 5 years old; approximately 3 to 7 percent of LGS patients die within a mean follow-up period of less than 10 years. The condition is difficult to treat, with patients often taking multiple antiepileptic drugs (AEDs) in attempts to control the seizures. The multiple types and frequency of seizures can lead to developmental delays, as well as behavioral disorders. Symptoms of LGS include a variety of seizure types, with tonic (muscle stiffening), atonic (loss of muscle tone/drop attacks) and absence (staring) seizures being the most common. Atonic seizures lead to the sudden falls seen in LGS patients known as "drop attacks," a primary cause of injury. Tonic-clonic (grand mal), myoclonic (sudden muscle jerks) and other seizure types can also occur.
"We've seen how BANZEL benefitted participants in our clinical trials and I'm so pleased that Eisai can offer this much needed new treatment option," said Lonnel Coats, President and Chief Operating Officer of Eisai Corporation of North America. "The approval of BANZEL further exemplifies our human health care (hhc) mission to bring treatments to the people who need them most."
BANZEL is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.
About the BANZEL Clinical Study