Outside the Zonegran: Eisai gets EU monotherapy extension
This article was originally published in Scrip
Executive Summary
Within days of publishing data that formed the basis of its marketing authorisation application (MAA), Eisai has received approval from the European Medicines Agency (EMA) extending the use of once-daily Zonegran (zonisamide) from adjunctive therapy to include monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy.