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°®¶¹´«Ã½. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (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.

Discovered and developed by Eisai, Fycompa is a non-competitive AMPA-type glutamate receptor antagonist. As an AMPA receptor antagonist, Fycompa reduces neuronal hyperexcitation associated with seizures by inhibiting glutamate activity at post-synaptic AMPA receptors. This is the first antiepileptic agent approved by the U.S. FDA to work in this manner.

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. The most commonly reported adverse events were dizziness, somnolence, fatigue, irritability, falls, nausea, ataxia, balance disorder, gait disturbance, vertigo and weight gain. Serious or life-threatening psychiatric (mental) problems were also seen more frequently in patients treated with Fycompa. These reactions are described in the boxed warning bolded below.

The FDA has recommended that Fycompa be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug under the country’s Controlled Substances Act. Once the DEA has provided the final scheduling designation, Eisai will announce when Fycompa will be available to patients and physicians in the United States.

There are an estimated 2.2 million people living with epilepsy in the United States, and more than 50 million people living with epilepsy worldwide. Eisai defines epilepsy as a therapeutic area of focus, with its currently marketed U.S. epilepsy portfolio comprising Zonegran® (under license from the originator, Dainippon Sumitomo Pharma Co., Ltd.) as an adjunctive treatment for adult epilepsy patients with partial-onset seizures, and Banzel® (under license from the originator, Novartis AG) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, a severe form of early childhood-onset epilepsy. By providing multiple treatment options as part of an abundant product portfolio in the field of antiepileptic drugs, Eisai seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families.

[ Please refer to the following notes for further information on epilepsy, Fycompa (perampanel), perampanel Phase III studies, and Eisai’s Commitment to Epilepsy. ]

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.
Epilepsy can develop at any age and 0.5% to 2% of people will develop epilepsy during their lifetime. Epilepsy reportedly affects nearly 1 million people in Japan, 2.4 million people in Europe (G5), 2.2 million people in the United States, and more than 50 million people worldwide. Epilepsy constitutes an area in which there are still significant unmet medical needs, with partial-onset epilepsy accounting for approximately 60% of all epilepsy cases in the United States, and from 25% to 30% of patients living with partial epilepsy in that country not achieving seizure freedom despite therapy with antiepileptic drugs.

Fycompa (perampanel), a novel chemical entity discovered and developed by Eisai, is a non-competitive AMPA-type glutamate receptor antagonist. Fycompa is the first antiepileptic treatment to reduce neuronal hyperexcitation associated with seizures by targeting glutamate activity at post-synaptic AMPA receptors. Fycompa has demonstrated anti-seizure effects in Phase II and III studies. The agent is approved in Europe and the United States as a treatment (once-daily oral dose) of partial-onset seizures, and is also being evaluated in a Phase III study in Asia including Japan. Furthermore, Eisai is conducting a global Phase III perampanel study for generalized epilepsy and Phase II perampanel studies in Europe and the United States for partial-onset epilepsy in pediatric patients, as it seeks to expand the range of indications for which the drug is approved.

[ Important Safety Information Summary in the United States ]
Mental (Psychiatric) Problems
Fycompa may cause new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability, being suspicious or distrustful (believing things that are not true) or other unusual or extreme changes in behavior or mood. Patients should call their healthcare provider right away if they have any new or worsening mental problems while taking Fycompa.

Suicidal Thoughts and Actions
Antiepileptic drugs, including Fycompa, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare provider right away if they have any new or worsening symptoms of depression, any unusual or sudden changes in mood, feelings, behavior, or suicidal thoughts, behavior, or thoughts of self-harm that they have never had before or may be worse than before.

Dizziness, Vertigo (Sense of Spinning) and Problems Walking Normally
Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of Fycompa is increased. A patient’s risk of feeling dizzy and having problems walking normally may be higher if they are elderly.

Sleepiness and Tiredness
Fycompa may make a patient feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how Fycompa affects them. A patient’s risk of feeling sleepy and tired may be higher if they are elderly.

Falls
Taking Fycompa may increase a patient’s chance of falling. These falls can cause serious injuries. A patient’s risk of falling may be higher if they are elderly.

Withdrawal of AEDs
Patients must not stop Fycompa without first talking to their healthcare provider. Stopping Fycompa suddenly can cause serious problems and can cause patients to have seizures more often.