Rufinamide

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

Retrieved on: 
Wednesday, November 2, 2022
MHLW, Patient, Safety, LGS, Lennox–Gastaut syndrome, Tablet, Ministry, AED, Seizure, Eisai, Pharmaceutical industry, Labour, Rufinamide, Health, Welfare

TOKYO, Nov 2, 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.

Key Points: 
  • TOKYO, Nov 2, 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.

Eisai Receives Approval for Indication Expansion of Anti-Epileptic Agent Fycompa for Use in Pediatric Patients

Retrieved on: 
Monday, November 16, 2020
Neurological disorders, Health, Clinical medicine, Anticonvulsants, Eisai, Lennox–Gastaut syndrome, Sodium channel blockers, Epilepsy, GABAA receptor positive allosteric modulators, Rufinamide, Zonisamide

Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients with epilepsy (from 2 to less than 12 years of age).

Key Points: 
  • Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients with epilepsy (from 2 to less than 12 years of age).
  • As we offer several treatment options in Europe, including Fycompa, Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with seizures associated with Lennox-Gastaut syndrome.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com
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