Eisai has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fycompa (perampanel), an AMPA receptor antagonist.
Fycompa (perampanel) is an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.
Perampanel is a highly selective, non-competitive AMPA-type glutamate receptor antagonist.
The positive opinion is based on three pivotal Phase III global double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients.
The studies showed consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in patients with partial-onset seizures (with or without secondary generalizations).
Eisai has also received a positive CHMP opinion for Zonegran (zonisamide) as monotherapy for the treatment of partial seizures (with or without secondary generalization) in adults with newly diagnosed epilepsy.
The Zonisamide approval is based on data from a double blind, randomized study designed to compare once-daily Zonegran with twice-daily controlled release carbamazepine as monotherapy in 583 patients.
Zonegran was effective and well tolerated in newly diagnosed epilepsy patients when used as monotherapy, in the multicenter study.
