The European Medicines Agency has cleared use of Bial and Eisai’s sodium channel blocker Zebinix for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy, widening its treatment scope in the region.
Zebinix (eslicarbazepine acetate) 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.
Also, the one-year seizure-freedom rate at the last evaluated dose was 64.7 percent on eslicarbazepine acetate and 70.3 percent on controlled-release carbamazepine, while safety profiles were similar, the firms noted.
The new approval, says Eugen Trinka, professor and chair of Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria, “brings the promise of a new monotherapy option for over half of patients with epilepsy who experience partial-onset seizures.”