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Tuesday, 18 June 2019, 12:11 HKT/SGT
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Source: Eisai
Eisai to Present Latest Data on Perampanel at 33rd International Epilepsy Congress

TOKYO, June 18, 2019 - (JCN Newswire) - Eisai Co., Ltd. announced today that the latest data on its antiepileptic drug (AED) perampanel (product name: Fycompa) will be presented at the 33rd International Epilepsy Congress (IEC) to be held from June 22 to 26, 2019 in Bangkok, Thailand.

As major presentations, 2 oral presentations will be given including on the final analysis of a Phase III clinical study (Study 311) on adjunctive perampanel in pediatric patients aged 4 to less than 12 years old with epilepsy. Also, a total of 12 poster presentations will be given, including on the primary analysis from a Phase III clinical study (FREEDOM / Study 342), which was conducted in Japan and South Korea, on the efficacy and safety of perampanel monotherapy in untreated epilepsy patients with partial-onset seizures (with or without secondary generalized seizures).

Perampanel is a first-in-class AED and a once-daily tablet discovered at Eisai's Tsukuba Research Laboratories. In the United States and Europe, an oral suspension formulation has been approved and is being marketed. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Perampanel is currently approved in countries around the world as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalized seizures) and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. Furthermore, in the United States, Perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy 4 years of age and older.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver perampanel throughout the world 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.

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 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 and is being marketed in the United States and Europe.

Perampanel is currently approved in more than 55 countries, 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. An application seeking approval for use in the adjunctive treatment of partial-onset seizures is under review in China, which has been designated for Priority Review. 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 tonic-clonic seizures in patients with generalized epilepsy 12 years of age and older. In the United States, 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 Japan, a supplementary new drug application has been filed seeking approval of perampanel for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a fine granule formulation. In Europe, an application has been submitted seeking the additional approval of perampanel for adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures in pediatric patients with epilepsy.

Furthermore, Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with epileptic seizures associated with Lennox-Gastaut syndrome.


About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

In its medium-term business plan EWAY2025, Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.

For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120


June 18, 2019 12:11 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
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