Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

ENGLISH
|
JAPANESE
|
CONNECT WITH US:

Nov 02, 2022 18:34 JST

Source: Eisai

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

TOKYO, Nov 02, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared.

In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: "Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product."

Based on the safety data in 702 patients and efficacy data in 495 patients submitted to the MHLW as the results of analyses of this all-case study, the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition.

Eisai will continually strive to promote the proper use of Inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.

For more information, visit www.eisai.com/news/2022/news202275.html.

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

Source: Eisai
Sectors: BioTech

Copyright ©2026 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Latest Release

Honda Motor Co, Ltd

Honda Makes Gachaco a Consolidated Subsidiary by Subscribing to New Shares of Gachaco Issued Through Third-party Allotment

Apr 01, 2026 22:09 JST

Denso

DENSO Hosted "DENSO DIALOG DAY 2026", Delivers Mid-Term Management Plan "CORE 2030"
Apr 01, 2026 21:54 JST

Mitsubishi Heavy Industries, Ltd.

MHI President Eisaku Ito Offers Words of Encouragement to New Employees at the Company's 2026 Welcoming Ceremony
Apr 01, 2026 13:35 JST

Mitsubishi Heavy Industries, Ltd.

MHI Completes the Transfer Procedures for its Domestic Onshore Wind Power Business
Apr 01, 2026 13:26 JST

Toyota Motor Corporation

Toyota Motor Corporation aims to join Daimler Truck and Volvo Group as equal shareholder in the fuel cell joint venture cellcentric
Mar 31, 2026 23:39 JST

Honda Motor Co, Ltd

Honda Announces the Establishment of PathAhead Co., Ltd., a Startup Originated from IGNITION, a Honda New Business Creation Program
Mar 31, 2026 21:58 JST

Hitachi, Ltd.

Hitachi Digital Services Strengthens OT-IT Integration with Manufacturing Operations Management Platform
Mar 31, 2026 19:14 JST

Fujitsu and Osaka University of Health and Sport Sciences partner to innovate sports performance with skeleton recognition AI
Mar 31, 2026 17:42 JST

NTT DOCOMO

DOCOMO and SK Telecom Publish White Paper on Requirements for Advancing vRAN and AI-RAN in Mobile Networks
Mar 31, 2026 11:00 JST

NEC Corporation

NEC Supports Ooredoo Algeria in Modernizing Enterprise Network Security with high-performance next-generation firewalls (NGFW)
Mar 31, 2026 10:50 JST

Hitachi, Ltd.

MOL and Hitachi Launch Initiative to Convert Used Ships into Floating Data Centers
Mar 30, 2026 19:21 JST

Resona Holdings, BrainPad, and Fujitsu sign basic agreement for collaboration to transform financial operations with data and AI and advance next-generation data utilization
Mar 30, 2026 15:55 JST

Mitsubishi Heavy Industries, Ltd.

MHI Innovative Combustion Dynamics Laboratory is Established at Kyoto University with the Aim of Developing and Socially Implementing World-Leading Technology
Mar 30, 2026 12:53 JST

Fujitsu launches generative AI service that analyzes source code and automatically generates design documents
Mar 30, 2026 10:41 JST

Eisai

Application Submitted for LENVIMA(R) (lenvatinib) in Japan Seeking Approval of Additional Dosage and Administration for Combination with WELIREG(R) (belzutifan) for Renal Cell Carcinoma that has Progressed After Chemotherapy
Mar 27, 2026 20:14 JST

Hitachi, Ltd.

Hitachi and MUFG Bank expand NextGen model to finance vehicles and charging infrastructure for decarbonized mobility
Mar 27, 2026 19:44 JST

Eisai

Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency
Mar 27, 2026 18:19 JST

Mitsubishi Heavy Industries, Ltd.

New "L00 Series" Train for the Seibu Railway's Yamaguchi Line Begins Commercial Operation
Mar 27, 2026 16:51 JST

Fujitsu develops high-sensitivity, high-resolution infrared sensor to expand monitoring capabilities in defense and disaster prevention
Mar 27, 2026 14:07 JST

Sharp Corporation

Sharp Develops Long-Range Video Monitoring Technology
Mar 26, 2026 22:39 JST

More Latest Release >>