Pharmaprojects R&D Pipeline News Feed
Zebinix receives EU approval
1 May 2009
The novel once-daily anti-epileptic Zebinix (eslicarbazepine acetate) has been granted marketing authorization from the European Commission. Zebinix was developed by Bial and is currently licensed to Eisai for co-promotion in Europe and to Sepracor for development and commercialization in the US and Canada.
The approval follows a positive opinion, received earlier this month, and three successful Phase III trials in 1049 patients with refractory partial epilepsy, conducted across 23 countries, that demonstrated efficacy, safety and tolerability, including a 50% reduction in seizure frequency. Zebinix also produced significant improvements in mean quality of life, as measured by Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores.
Bial has also filed a US NDA, with launch expected in 2010. Bial and Eisai plan to launch Zebinix across the EU in 2009-2010.
