FDAnews
www.fdanews.com/articles/182193-european-commission-grants-approval-to-zebinix

European Commission Grants Approval to Zebinix

June 13, 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.

View today's stories