Eisai to file Zonegran as first-line epilepsy therapy in Europe on good trial results
Based on the positive results of a late-stage clinical trial, Japanese drug major Eisai’s (TYO: 4523) European subsidiary plans to seek European Medicines Agency approval for a first-line monotherapy indication for zonisamide in newly-diagnosed adults with epilepsy.
The company said that a new Phase III study (E2090-E044-310 Monotherapy Study) which showed that the anti-seizure treatment Zonegran (zonisamide/ZNS) is effective and well tolerated in newly diagnosed epilepsy patients when used as monotherapy.
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