Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Wednesday, 25 May 2016, 15:25 HKT/SGT
Share:
    

Source: Eisai
Eisai to Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate)
As Adjunctive Therapy for Partial-Onset and Generalized Tonic-Clonic Seizures in Japan

TOKYO, May 25, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it will launch its in-house-discovered antiepileptic drug (AED) Fycompa Tablets 2 mg and 4 mg (perampanel hydrate) as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs in Japan on May 26, 2016. Eisai received marketing and manufacturing approval for this formulation on March 28, 2016, and the product has been added to Japan's National Health Insurance drug price list as of today.

Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, Fycompa is a first-in-class AED, available in tablet form as a once-daily oral dose. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. In both a Phase III clinical study (Study 335)(1) of adjunctive Fycompa in refractory partial-onset seizures, as well as a Phase III clinical study (Study 332)(2) of adjunctive Fycompa in primary generalized tonic-clonic (PGTC) seizures, Fycompa demonstrated a statistically significant reduction in seizure frequency. Furthermore, in Study 332, 30.9% of patients treated with Fycompa were free of PGTC seizures during the 13 week maintenance period (12.3% for placebo). The most common adverse events (>/= 10% in the perampanel arms and greater than placebo) observed in Studies 332 and 335 were dizziness, fatigue, headache, somnolence and irritability.

Epilepsy affects approximately 1 million people in Japan. 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%. PGTC seizures are one of the most common and most severe forms of generalized seizures, accounting for approximately 60% of generalized seizures and approximately 20% of all epilepsy cases.(3) The frequency of generalized tonic-clonic seizures is the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP).(4) As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs,(5) this is a disease with significant unmet medical needs.

Fycompa is currently approved in more than 45 countries and territories, including Europe and the United States, as an adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in adult and adolescent patients with epilepsy 12 years of age and older. Fycompa has been also been approved in more than 35 countries, including Europe and the United States, for the adjunctive therapy of PGTC seizures in patients with epilepsy 12 years of age and older.
Eisai considers neurology a therapeutic area of focus, and by providing Fycompa as a new treatment option in Japan in addition to the AEDs Inovelon and Fostoin as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

(1) Nishida T, et al. "A randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of perampanel as adjunctive therapy in patients with refractory partial-onset seizures from the Asia-Pacific region." Abstract. 69th American Epilepsy Society (AES) Annual Meeting, 2015; 3.256
(2) French JA, et al. "Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy." Neurology 2015; 85, 950-957
(3) Hauser WA, et al. Epilepsia, 34(3):453-468,1993
(4) Shorvon S, Tomson T. "Sudden unexpected death in epilepsy." Lancet, 2011; 378:2028-2038
(5) "The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?" National Institute of Neurological Disorders and Stroke, accessed May 24, 2016, http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109


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.
+81-3-3817-5120



May 25, 2016 15:25 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2020 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Jan 6, 2020 08:57 HKT/SGT
Eisai's Fycompa for Adjunctive Treatment of Partial Onset Seizures Launched in China
Dec 24, 2019 16:22 HKT/SGT
Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval
Dec 23, 2019 08:17 HKT/SGT
U.S. FDA Approves Eisai's Dayvigo (Lemborexant) for Treatment of Insomnia in Adult Patients
Dec 10, 2019 08:02 HKT/SGT
Commencement of Major Renovation of Tsukuba Research Laboratories as Eisai Global Drug Discovery Center Aiming for Connecting Human and Human, and Data, and the World
Dec 9, 2019 08:36 HKT/SGT
Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer's Disease Using Blood
Dec 9, 2019 08:17 HKT/SGT
Eisai Satisfies All-Case Surveillance Condition for Approval of Anti-Cancer Agent Lenvima in Treatment of Thyroid Cancer
Dec 5, 2019 08:11 HKT/SGT
Eisai to Present New Research on Eribulin (Halaven) at 42nd Annual San Antonio Breast Cancer Symposium
Dec 2, 2019 08:23 HKT/SGT
Eisai to Present Latest Data on Alzheimer's Disease / Dementia Pipeline at 12th Clinical Trials on Alzheimer's Disease Conference
Dec 2, 2019 08:08 HKT/SGT
Eisai: Additional Indication for Lenvima (Lenvatinib) for Differentiated Thyroid Cancer Accepted in China
Nov 26, 2019 08:37 HKT/SGT
Eisai to Present Latest Data on Perampanel at the 73rd American Epilepsy Society Annual Meeting
More news >>
 News Alerts
Copyright © 2020 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 400 879 3881 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6859 8575

Connect With us: