November 22, 2023
Eisai Co., Ltd.

No. 23-71

EISAI TO PRESENT LATEST DATA ON PERAMPANEL AT THE 77TH AMERICAN
EPILEPSY SOCIETY (AES) ANNUAL MEETING
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will
have a total of nine poster presentations, including the latest data on its in-house discovered and developed
anti-epileptic agent (AED) perampanel (product name: Fycompa®) at the 77th American Epilepsy Society
Annual Meeting (AES 2023), to be held in Orland, Florida and virtually from December 1-5, 2023.
Major presentations include the design and outcomes of a clinical research evaluating the safety ofperampanel versus placebo (Poster No. 1.493), and the data of evaluating the effects of perampanel on
cognitive function and sleep (Poster No. 2.157, 2.158 and 2.160).
Eisai considers neurology, including epilepsy, a therapeutic area of focus. Eisai pursues its mission toprovide “seizure freedom” to a greater number of patients with epilepsy. Eisai remains committed furtherto addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and theirfamilies.
The following are studies that will be presented by Eisai at this year’s AES Annual Meeting.
Poster presentations
CompoundPoster Number
Planned Date and Time

Title

(Eastern Standard Time)
Perampanel
Poster No: 1.493
December 2 (Sat) 12:00-14:00

Ability of Time to Prerandomization Seizure Count Design to Measure
Safety of Perampanel for Primary Generalized Tonic-Clonic Seizures

Perampanel

Study 512: Effect of Perampanel on Seizure Control, Sleep, and Quality

Poster No: 2.157
December 3 (Sun) 12:00-14:00

of Life in Patients with Focal-Onset Seizures/Generalized Tonic-ClonicSeizures Associated with Idiopathic Generalized Epilepsy

Perampanel

A Mirroring Clinical Practice Study of Perampanel in Adults andPoster No: 2.158
December 3 (Sun) 12:00-14:00

Adolescents (AMPA): Effect of Adjunctive Perampanel on Daytime
Sleepiness and its Correlation with Seizure Control

Perampanel
Poster No: 2.159
December 3 (Sun) 12:00-14:00

A Mirroring Clinical Practice Study of Perampanel in Adults andAdolescents (AMPA): Assessment of Daytime Sleepiness in Patients withEpilepsy Treated with Adjunctive Perampanel

Perampanel
Poster No: 2.160

Study 512: Assessment of Cognitive Function (EpiTrack®) FollowingPerampanel as First Adjunctive Therapy in Adolescent and Adult Patients

December 3 (Sun）12:00-14:00

with Epilepsy

Perampanel

Study 512: Overall Effectiveness and Safety of Perampanel in Patients

Poster No: 2.162
December 3 (Sun) 12:00-14:00

Aged ≥ 12 Years with Focal-Onset Seizures or Generalized Tonic-Clonic
Seizures Associated with Idiopathic Generalized Epilepsy

Perampanel

Effectiveness and Safety/Tolerability of Perampanel for Treatment of

Poster No: 2.274
December 3 (Sun) 12:00-14:00

People with Epilepsy with Genetic Etiology: Real-World Evidence fromthe PERMIT Extension Study

Perampanel
Poster No: 2.275

Perampanel for Treatment of Focal and Generalized Seizures in People
with Different Epilepsy Etiologies in Everyday Clinical Practice: TheDecember 3 (Sun) 12:00-14:00

PERMIT Extension Study

Perampanel
Poster No: 2.276

Effectiveness and Safety/Tolerability of Perampanel for Treatment ofFocal and Generalized Seizures in Clinical Practice According toDecember 3 (Sun) 12:00-14:00

Concomitant Antiseizure Medications: the PERMIT Extension StudyMedia Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120[Notes to Editors]
1.

About perampanel (product name: Fycompa)

Perampanel is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai. With epileptic seizures
being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor
antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA
receptors on postsynaptic membranes. Perampanel is currently approved in more than 75 countries and territories,
including Japan, China, and other countries in Europe and in Asia as an adjunctive treatment for partial-onset seizures(with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In addition,perampanel has been approved in more than 70 countries, including Japan, in Europe and in Asia for treatment as an
adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. InJapan and China, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset
seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. In Europe
the approved age range is 4 years of age and older for the adjunctive treatment of partial-onset seizures (with orwithout secondarily generalized seizures) and 7 years of age and older for the treatment as an adjunctive therapy forprimary generalized tonic-clonic seizure. Perampanel is available in drug form to be taken once daily orally at bedtime.
A tablet and fine granule formulation have been approved in Japan. An oral suspension formulation and tablet havebeen approved in Europe and China. A supplementary new drug application for an injection formulation has been
submitted in Japan as a new route of administration. In January 2023, the commercial rights in the United States weretransferred.
2.

About Epilepsy

Epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of
epilepsy cases and generalized seizures accounting for approximately 40%. In a partial-onset seizure, an abnormalelectrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain,
becoming a generalized seizure (known as a secondarily generalized seizure). In a generalized seizure, abnormal
electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physicalsymptoms manifested throughout the whole body.
Epilepsy affects approximately 1 million people in Japan, 3.4 million people in the United States, 6 million people inEurope, 9 million people in China, and approximately 60 million people worldwide. As approximately 30% of patientswith epilepsy are unable to control their seizures with currently available AEDs,* this is a disease with significant unmet
medical needs. Although onset occurs at any age, onset is most common in people aged 18 and younger and theelderly. As causes and clinical symptoms of pediatric epilepsy are not uniform, and prognoses can range from very
positive cases to obstinate cases, special consideration for each patient is required of treatments.
*“The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?” National Institute of Neurological Disorders andStroke, accessed May 24, 2016, http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109