Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa (perampanel) for the adjunctive treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older.

Perampanel, a novel chemical entity discovered and in development by Eisai, is a highly selective, non-competitive AMPA-type glutamate receptor antagonist. If approved, perampanel will be the first product in this new class of anti-epileptic drugs to gain regulatory approval.

The CHMP based its decision on clinical data from 3 pivotal phase III, global, randomized, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients. Each of the studies showed consistency with the preferable results in seizure control as adjunctive therapy across all partial onset seizure types, including secondary generalization. The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls, and ataxia. According to the CHMP positive opinion, perampanel is expected to contribute to patients with epilepsy aged 12 years and older, that is adults and adolescents. Additionally, perampanel delivers the benefit of once-daily dosing, thereby facilitating adherence to treatment. Based on CHMP’s recommendation, EU approval of the new therapy is anticipated within three months.

Eisai defines epilepsy as a therapeutic area of focus, and seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families by providing them with multiple treatment options as part of its abundant epilepsy franchise product portfolio.

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. A patient is considered to have epilepsy after two or more unprovoked seizures. A seizure occurs when a brief, strong surge of electrical activity affects part or all of the brain. An individual can have various symptoms, from convulsions and loss of consciousness, to some that are not always recognized as seizures, such as blank staring, lip smacking, or jerking movements of arms and legs.

Fycompa is a novel chemical entity discovered and in development by Eisai, is a highly selective, non-competitive AMPA -type glutamate receptor antagonist. Perampanel is the first anti-epileptic treatment to reduce neuronal hyperexcitation associated with seizures by targeting glutamate activity at post-synaptic AMPA receptors. Perampanel has demonstrated broad-spectrum anti-seizure effects in phase II and III studies.

The agent has received a positive opinion from the CHMP for the adjunctive treatment of partial-onset seizures in Europe, is currently under regulatory review for NDA in the United States, and is also being evaluated in phase III studies in Japan. Furthermore, Eisai is conducting a global phase III studies for generalized epilepsy and plans to conduct further studies for usage as monotherapy in the treatment of partial-onset seizures, Lennox-Gastaut syndrome and other forms of epilepsy as it seeks to expand the range of indications for which the drug is approved.

Eisai defines epilepsy as a therapeutic area of focus, not only developing Fycompa (Perampanel) globally, but currently marketing Zonegran (under license from the originator Dainippon Sumitomo Pharma Co., Ltd.