Eisai applies to EMA to extend use of Zonegran to children for treatment of partial seizures

The EMA has accepted the submission of an application to extend the use of Epilepsy drug Zonegran (zonisamide), from Eisai, in the treatment of partial seizures (with or without secondary generalisation) to include children aged six years and above. A decision on this new licence extension application is expected in September 2012.

This submission was based on data from the double-blind, randomised, multicentre, placebo-controlled Phase III CATZ study, which showed that zonisamide is more effective than placebo, and well tolerated in paediatric epilepsy patients (6-17 years) with partial-onset seizures treated with one or two other anti-epileptic drugs. Results showed that significantly more patients responded positively to treatment with zonisamide (50.5%) versus treatment with placebo (31.0%).

In early July 2012, the EMA issued Marketing Authorisation Approval to extend the use of zonisamide to include monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy.