Eisai Co., Ltd. has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) on the license extension application submitted by its UK subsidiary Eisai Ltd. regarding the use of antiepileptic agent Zonegran (zonisamide) in the treatment of paediatric patients. The application seeks to extend 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 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 on June 27, 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.
In a double-blind, randomized, multi-centre, placebo-controlled, pivotal phase III study (Study 312) conducted to evaluate adjunctive zonisamide in 207 paediatric patients (six to 17 years) with partial seizures who had received one or two AEDs, results showed that the proportion of responders (defined as 50 per cent 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 diarrhoea.
Eisai defines epilepsy as a therapeutic area of focus and as part of its European epilepsy pipeline 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 abundant 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 defines epilepsy as a therapeutic area of focus. As of July 2013, the company’s in-house-developed AMPA receptor antagonist Fycompa (perampanel) has been approved as a novel treatment for partial seizures in over 30 countries, including the United States and in Europe, having been launched in various EU member states since September 2012.