Eisai Receives European Commission Approval on Use of Antiepilep
Eisai Receives European Commission Approval on Use of Antiepileptic Agent Zonegran in Pediatric Patients
Tokyo, Oct 3, 2013 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that it has received approval from the European Commission (EC) on the license extension application submitted by its U.K. subsidiary Eisai Ltd. regarding the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients. The approval extends the use of adjunctive Zonegran in the treatment of partial seizures (with or without secondary generalization) by changing the approved age range from adults aged 18 years and above to now also include pediatric patients aged 6 years and above.
Zonegran is an antiepileptic drug (AED) originally created by Dainippon Pharmaceutical Co., Ltd. (currently Dainippon Sumitomo Pharma Co., Ltd.), for which Eisai has been pursuing development of the agent in Europe. Zonegran was first approved in March 2005 as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalization) in adults with epilepsy and received additional approval in June 2012 as a monotherapy for partial-onset seizures in adults with newly diagnosed epilepsy. The agent is currently marketed in Europe by Eisai's subsidiaries.
The data used in the application was from a double-blind, randomized, multicenter, placebo-controlled, pivotal Phase III study (Study 312) that evaluated adjunctive zonisamide in 207 pediatric patients (6 to 17 years) with partial seizures who had received one or two AEDs. The results of the study showed that the proportion of responders (defined as 50 percent or greater reduction in seizure frequency) was significantly higher with zonisamide versus treatment with placebo. The overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo. TEAEs reported more frequently with zonisamide versus placebo were decreased appetite, decreased weight, somnolence, vomiting and diarrhea.
Eisai defines epilepsy as a therapeutic area of focus and in Europe markets the novel, in-house-discovered AMPA receptor antagonist Fycompa (perampanel), Zonegran and Zebinix as treatments for partial seizures and Inovelon as a treatment for seizures associated with Lennox-Gastaut syndrome, a severe form of childhood-onset epilepsy. By offering multiple treatment options as part of its product portfolio in the epilepsy area, Eisai seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients with epilepsy and their families.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
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