Eisai’s New Drug Application for Perampanel Designated for Priority Review by China National Medical Products Administration

For Adjunctive Treatment of Partial Onset Seizures

Tokyo, January 05, 2019: Eisai Co., Ltd. announced that its in-house discovered and developed antiepileptic drug (AED) perampanel (generic name, product name: Fycompa), for which a New Drug Application (NDA) was submitted for review as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older in China in October 2018, has been designated for Priority Review by the National Medical Products Administration (NMPA) due to perampanel’s significant clinical benefit compared to existing treatments.

The Priority Review and Approval procedure was implemented by the NMPA in February 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under the procedure the period of time until approval is expected to be shortened.

In China, it is estimated that there are approximately 9 million patients with epilepsy, with approximately 60% being affected by partial-onset seizures, and 40% of these patients with partial-onset seizures require adjunctive treatment.(1) As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs,(2) this is a disease with significant unmet medical need.

Perampanel is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. Administered orally once-daily, it 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 has been approved in over 55 countries around the world 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 over 50 countries around the world as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In the United States, perampanel is also indicated 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.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and is striving to deliver perampanel to patients in China as soon as possible. In pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy, Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

(1) Clinical Guideline 2015 in China
(2) “The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?” National Institute of Neurological Disorders
and Stroke, accessed May 24, 2016
(3) Nishida T., et al. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018; 137:392-399

About perampanel (generic name, product name: Fycompa)

Perampanel is a first-in-class 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 available in tablet form to be taken once daily orally at bedtime. In addition, an oral suspension formulation has been approved in the United States.

Perampanel is currently approved in more than 55 countries and territories, including the United States, Japan, in Europe and in Asia as 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 50 countries, including the United States, 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. In the United States, perampanel is also indicated 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.

Furthermore, Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with seizures associated with Lennox-Gastaut syndrome. In Japan and Europe, Eisai is conducting a Phase III study in pediatric patients with epilepsy (Study 311) and plans to submit a marketing authorization application in fiscal 2018. Additionally, positive topline results have been obtained in a Phase III study (Study 342) of perampanel as monotherapy in untreated patients with partial-onset seizures 12 years of age and older currently being conducted in Japan on November 2018. Based on these topline results, the company plans to submit a regulatory application in Japan for perampanel as monotherapy during fiscal 2018.

Corporate Comm India(CCI Newswire)