EMA widens scope of Zebinix (eslicarbazepine acetate) for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. - Bial + Eisai

The European Medicines Agency has approved the use of Zebinix (eslicarbazepine acetate) from Bial + Eisai for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy, widening its treatment scope in the EU. Zebinix is already indicated in Europe as adjunctive therapy in adults, adolescents and children aged above six years, with partial-onset seizures with or without secondary generalisation.

The approval came after clinical data from a late-stage non-inferiority trial showed that 71.1 percent of patients taking the drug once-daily were seizure-free for six months or more compared to 75.6 percent of those taking twice-daily, controlled-release carbamazepine.