Eisai has 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.
A double-blind, placebo-controlled pivotal study of Lennox-Gastaut syndrome (LGS) patients treated with Banzel as adjunctive therapy showed a 42.5% 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% median increase for placebo-treated patients. Drop attacks are a primary cause of injury in LGS patients. Banzel for LGS will be available to the public in January 2009.
Lonnel Coats, president and COO of Eisai Corporation of North America, said: “We’ve seen how Banzel benefited participants in our clinical trials and I’m so pleased that Eisai can offer this much needed new treatment option. The approval of Banzel further exemplifies our human health care mission to bring treatments to the people who need them most.”