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Eisai’s epilepsy drug Zebinix receives European approval
Eisai and its development partner Bial has announced that its epilepsy drug Zebinix has received approval from the European Medicines Agency.
The therapy has been approved for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy, having previously been indicated as an adjunctive therapy in adults, adolescents and children aged six and above with partial-onset seizures, with or without secondary generalisation.
Data from a phase III study comparing Zebinix as a monotherapy to twice-daily, controlled-release carbamazepine showed that Eisai's therapy was able to deliver improvements in terms of seizure freedom, and was used to support this approval.
To date, the efficacy of Zebinix has been demonstrated in an initial proof-of-concept phase II study and three subsequent phase III studies, enrolling 1,049 people with refractory partial onset seizure in total.
Neil West, vice-president for Europe, the Middle East and Africa at Eisai's global neurology business, said: "This milestone means that newly diagnosed adult patients in Europe who experience partial-onset epilepsy will now have a broader range of treatment options available."
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