FDA approves Fycompa (Eisai) as a treatment for Epilepsy

Eisai Inc. has received approval on 22 October 2012 from the FDA for the AMPA receptor antagonist Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with Epilepsy age 12 years and older.

The approval decision was based primarily on clinical data from three pivotal Phase III, global, randomized, double-blind, placebo-controlled, dose-escalation studies that examined 1,480 patients with partial-onset seizures. These studies demonstrated that Fycompa, as an adjunctive therapy, significantly reduced seizure frequency in patients with partial-onset seizures with or without secondary generalized seizures.

Fycompa was EU approved in July 2012.