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 ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease Accepted by European Medicines Agency
January 27 2023 10:46 JST
 
Eisai Commences Business Activities at New Pharma Sales Subsidiary in Israel
January 19 2023 09:35 JST
 
Eisai Listed as a Global 100 Most Sustainable Corporation for The Seventh Time Highest Ranked Global Pharmaceutical Company
January 19 2023 08:07 JST
 
Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023
January 18 2023 12:28 JST
 
Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan
January 16 2023 17:56 JST
 
Eisai Launches Renewed Sustainability Page
January 13 2023 14:06 JST
 
Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Europe
January 11 2023 11:52 JST
 
Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease
January 09 2023 20:55 JST
 
FDA Approves LEQEMBI (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
January 09 2023 19:40 JST
 
Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging
December 22 2022 17:07 JST
 
More Press release >>

Latest Press Release


More Latest Release >>