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.
Eisai Co., Ltd.
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