ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
*
Home
Press release
Oct 16, 2020 13:44 JST
Source:
Eisai
Eisai: Supplementary New Drug Applications for Anti-Epileptic Drug Fycompa as Monotherapy for Partial-Onset Seizures
Pediatric Indication for Partial-Onset Seizures Accepted in China
TOKYO, Oct 16, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that the supplementary new drug applications for its in-house discovered and developed anti-epileptic drug (AED) Fycompa (generic name: perampanel) as monotherapy for partial-onset seizures and pediatric indication for partial onset seizures in patients with epilepsy 4 years or older have been accepted in China by the National Medical Products Administration.
The submission covering monotherapy for partial-onset seizures was based on subgroup analysis estimating monotherapy safety and efficacy within clinical studies of the combination therapy (Study 304, 305, 306, and 335) conducted globally including the United States, Europe and China on patients ages 12 years and older with partial-onset seizures (with or without secondarily generalized seizures). Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data.
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 conducted globally on pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
In China, it is estimated that there are approximately 9 million patients with epilepsy, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs1, this is a disease with significant unmet medical needs.
Fycompa is a first-in-class AED and a once-daily tablet discovered at Eisai's Tsukuba Research
Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Fycompa has been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
Eisai considers neurology, including epilepsy, a therapeutic area of focus. With the acceptance of these additional applications regarding Fycompa in China, Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy across the world. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
For more information, visit
https://www.eisai.com/news/2020/pdf/enews202064pdf.pdf
.
Source: Eisai
Sectors: Healthcare & Pharm
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Latest Release
DENSO Acquires Axia Vegetable Seeds to Realize Sustainable Agriculture
Jul 04, 2025 16:20 JST
MHIET Launches 450kW Gas Cogeneration System Capable of Hydrogen Co-Firing
Jul 04, 2025 15:13 JST
Yachiyo Engineering and NEC launch adaptation finance study in Indonesia to calculate the adaptation value of disaster prevention measures
Jul 04, 2025 13:25 JST
Fujitsu to implement store monitoring solution for METRO Inc. in Canada, enhancing operational efficiency and policy compliance
Jul 04, 2025 13:19 JST
Fujitsu to develop ETF trading platform based on TSE's CONNEQTOR and provide it to Australian Securities Exchange
Jul 03, 2025 11:14 JST
Mitsubishi Motors Launches the All-New Grandis for the European Market
Jul 02, 2025 12:10 JST
Valuufy partners with Mainichi Future Creation Lab, Supporting New Approaches to Business Sustainability
Jul 02, 2025 12:00 JST
Fujitsu launches solution to enhance customers' global supply chain resilience
Jul 02, 2025 11:32 JST
MHI Receives Order to Supply Four Circulating Water Pumps for Units 5 and 6 of Sanmen Nuclear Power Plant in China Under Collaboration with Dongfang Electric Machinery
Jul 02, 2025 11:30 JST
Multi-purpose Arena in Odaiba Aomi Area TOYOTA ARENA TOKYO Construction Completed
Jul 01, 2025 22:56 JST
1Finity, a Fujitsu company, commences operations and reveals brand identity
Jul 01, 2025 22:53 JST
MHI Thermal Systems Begins Field Test of Jointly Developed "Surplus Renewable Energy Absorption and Release System"
Jul 01, 2025 22:40 JST
Japan's Telecommunications Carriers Strengthen Disaster Response Through Collaborative Information Sharing
Jul 01, 2025 22:30 JST
JCB and Mandai Wildlife Group Deepen Partnership with exclusive discounts for JCB cardmembers
Jul 01, 2025 16:00 JST
Fujitsu provides Japan's first AI-powered cloud-based library search service
Jul 01, 2025 11:30 JST
JCB Brings Apple Pay to Cardmembers in Vietnam
Jul 01, 2025 11:15 JST
First Shipment of LNG from the LNG Canada Project
Jul 01, 2025 11:00 JST
Approval in Principle (AiP) for World's First LCO2 / Methanol Carrier
Jun 30, 2025 20:30 JST
Acropolis Rally Greece: Day 4 Sunday success and second overall for TOYOTA GAZOO Racing's Ogier
Jun 30, 2025 20:15 JST
Mitsubishi Fuso-Hino Merger: 4 Firms Collaborate for the Future of Commercial Vehicles
Jun 30, 2025 20:10 JST
More Latest Release >>
Related Release
Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
6/2/2025 5:46:00 PM JST
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
5/28/2025 5:45:00 PM JST
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
5/21/2025 3:00:00 PM JST
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
5/16/2025 5:21:00 PM JST
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
4/30/2025 2:17:00 PM JST
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
4/18/2025 4:52:00 PM JST
Eisai to Divest Rights for Pariet in China to Peak Pharma
4/1/2025 1:15:00 PM JST
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
3/25/2025 5:28:00 PM JST
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
3/25/2025 12:21:00 PM JST
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
3/10/2025 8:24:00 PM JST
More Press release >>