Eisai Inc. announced today that it received approval from the FDA for an indication expansion for Eisai’s antiepileptic drug (AED) Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. Fycompa was designated for Priority Review by the FDA, and was approved approximately six months after submission.
Through this latest approval, Fycompa is indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. This approval was based on the interim results of a Phase III clinical study (Study 311) as well as the results from a Phase II clinical study (Study 232) in pediatric patients with epilepsy. Both studies confirmed the safety and efficacy of Fycompa were similar between adult and pediatric patients.