eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) 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.
public relations department,
eisai co., ltd.