FDA approves expanded indication for Fycompa in pediatric patients with partial-onset seizures.- Eisai.

The FDA has expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII, from Eisai, for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both Fycompa tablet and oral suspension formulations.

The use of Fycompa for the treatment of partial-onset seizures in adolescents and children 4 to below 12 years with epilepsy is supported by efficacy extrapolated from three Phase III adequate and well-controlled studies of Fycompa in adult patients with POS. Safety was evaluated in two studies in pediatric patients 4 to less than 12 years of age with epilepsy, a total of 225 patients received Fycompa, with 110 patients exposed for at least 6 months, and 21 patients for at least 1 year. Adverse reactions in pediatric patients 4 to less than 12 years of age were similar to those seen in patients 12 years of age and older. Final results of these studies supporting the FDA approval in pediatric patients 4 years and older will be presented at an upcoming medical meeting.

Comment: Fycompa was initially approved for adjunctive use in POS in 2012, and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. To date, Fycompa is approved in 55 countries and has treated more than 200,000 patients worldwide across all indications.