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news.Eisai has received the European Medicines Agency (EMA) acceptance for reviewing its license extension application for the usage of the company's antiepileptic drug Zonegran (zonisamide) as a monotherapy, which was earlier approved as an adjunctive therapy.
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With this license extension application, the company is seeking marketing approval from the EMA for Zonegran as a monotherapy for patients suffering from epilepsy with partial seizures, with and without secondary generalization.
The submission of the application was done on the basis of a multicenter, double-blind, randomized study comparing daily zonisamide with twice-daily controlled release carbamazepine as monotherapy.
The study involved around 583 adult patients with newly diagnosed partial-onset epilepsy.
The results of the trial suggested that zonisamide was effective and well tolerated when used as a monotherapy in newly diagnosed epilepsy patients.