Jan, 30 2019 16:22 JST

Source: Eisai

Eisai's Supplementary New Drug Application Submitted In Japan for Fycompa

As Monotherapy for Partial-Onset Seizures, Pediatric Indication for Partial-Onset Seizures, as Well as New Formulation

TOKYO, Jan, 30 2019 - (JCN Newswire) - Eisai Co., Ltd. has filed a supplementary new drug application in Japan for its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) seeking approval 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 new fine granule formulation.

The submission covering monotherapy for partial-onset seizures was based on the results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea. In FREEDOM, the percentage of untreated patients from 12 to 74 years of age with partial onset seizures who achieved seizure freedom with Fycompa monotherapy exceeded the criteria for efficacy, and the primary endpoint was met. The most common adverse events (incidence of 10% or higher) observed in this study were dizziness, somnolence, nasopharyngitis and headache, which is consistent with the safety profile of Fycompa to date.

The submission covering partial-onset seizures in pediatric patients was based on the results of a Phase III clinical study (Study 311) of Fycompa as adjunctive therapy in pediatric patients conducted in Japan, the United States and Europe. In Study 311 which evaluated Fycompa in pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures, it was demonstrated that the safety and efficacy of Fycompa in pediatric patients was similar to that observed in patients 12 years of age and older.

In addition, regarding the additional application for the fine granule formulation, Eisai developed this formulation to make it easier to administer Fycompa to children and patients who have difficulty taking tablets, and subsequently conducted a clinical study verifying bioequivalence with the tablet formulation, which led to this application.

Detailed results of FREEDOM and Study 311 will be presented at upcoming academic conferences.

Discovered at Eisai's Tsukuba Research Laboratories, Fycompa is a first-in-class AED that is a highly selective, noncompetitive AMPA receptor antagonist which reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Available in tablet form to be taken orally once daily, Fycompa is approved in Japan 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.

It is estimated that there are approximately 1 million patients with epilepsy in Japan, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and in continued 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 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.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com


Contact:
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Source: Eisai
Sectors: BioTech, HealthCare

Copyright ©2019 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai: Japan MHLW Grants Sakigake Designation to Novel Fibroblast Growth Factor (FGF) Receptor Selective Tyrosine Kinase Inhibitor E7090
April 08 2019 13:06 JST
 
Eisai to Launch Chocola BB Sparkling Kiwi & Lemon Flavor
April 08 2019 10:43 JST
 
Eisai to Launch "Travelmin Support" as Series' First Quasi-Drug
April 05 2019 09:45 JST
 
Eisai: Data Safety Monitoring Board Recommends Continuation of Phase III Clinical Studies of Bace Inhibitor Elenbecestat in Early Alzheimer's Disease
March 29 2019 10:46 JST
 
Eisai's Initiation of Phase III Clinical Trial of BAN2401 in Early Alzheimer's Disease
March 22 2019 10:37 JST
 
Eisai to Present Latest Research on Alzheimer's Disease / Dementia Pipeline at the 14th International Conference on Alzheimer's & Parkinson's Diseases
March 22 2019 10:23 JST
 
Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer's Disease
March 21 2019 23:25 JST
 
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
March 12 2019 07:43 JST
 
Eisai's Marketing Authorization Application for Potential Insomnia Disorder Treatment Lemborexant Submitted in Japan
March 07 2019 11:30 JST
 
Eisai Enters Into Agreement to Support International Ngo Association for Aid and Relief, Japan's Activities in Sudan
February 27 2019 10:52 JST
 
More Press release >>

Latest Press Release


More Latest Release >>