FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

European Commission Grants Approval to Zebinix

June 14, 2017

Bial and Eisai’s Zebinix (eslicarbazepine acetate) has been approved in the European Union for use as once-daily monotherapy for the treatment of adults with a newly diagnosed partial onset epilepsy.

Zebinix is already indicated in Europe as an adjuvant treatment in adult patients, adolescents and children over 6 years old with partial onset seizures, with or without secondary generalization.

Zebinix is a blocker of voltage-regulated sodium channels.

Clinical data showed that 71.1 percent of patients treated with Zebinix did not experience seizures for six months or more with the last dose evaluated.

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