Japanese pharmaceutical firm Eisai has secured approval from the European Commission (EC) on the license extension application for the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients.
The EC approval extends the use of adjunctive Zonegran, an antiepileptic drug (AED), in the treatment of partial seizures by changing the approved age range from adults aged 18 years and above to now also include pediatric patients aged six years and above.
Dainippon Pharmaceutical has developed Zonegran, for which Eisai has been pursuing development in Europe.
In March 2005, the drug was first approved as an adjunctive therapy for the treatment of partial-onset seizures 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 data used in the application, submitted by the company's UK subsidiary, was from a double-blind, randomized, multicenter, placebo-controlled, pivotal Phase III study that assessed adjunctive zonisamide in 207 pediatric patients with partial seizures who had received one or two AEDs.
The Phase III results showed that the proportion of responders (defined as 50% or greater reduction in seizure frequency) was significantly higher with zonisamide compared to treatment with placebo.