The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. It is already indicated in Europe as an adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Epilepsy ECG
“Epilepsy is a chronic disorder of the brain and one of the most common neurological conditions worldwide,” said Eugen Trinka, professor and chair of the department of neurology, Christian Doppler Klinik, Paracelsus Medical University, Austria. “This approval brings the promise of a new monotherapy option for over half of patients with epilepsy who experience partial-onset seizures.”
Eslicarbazepine acetate is a voltage-gated sodium channel blocker that selectively targets the slow inactivated state of the sodium ion channel, which has been indicated in the pathogenesis of epilepsy. It is currently marketed in Europe and Russia by Bial and its licensee, Eisai Europe.
“We are pleased that adults with partial-onset epilepsy across Europe are now able to benefit from a once-daily monotherapy option that is simple to use, which may optimise their adherence,” added António Portela, CEO of Bial, Portugal. “Bial has an ongoing commitment to all people living with epilepsy and we look forward to continuing to work with the epilepsy community to bring this new indication to patients.”
“This decision for eslicarbazepine acetate by the European Commission reinforces Eisai’s commitment to researching and developing neurological treatment options that have the potential to help people manage epilepsy more effectively,” stressed Neil West, vice president EMEA, global neurology business unit at Eisai. “This milestone means that newly-diagnosed adult patients in Europe who experience partial-onset epilepsy will now have a broader range of treatment options available.”
The authorisation has been based on the results of a Phase III, randomised, double-blind, active controlled, non-inferiority study, comparing once-daily eslicarbazepine acetate as monotherapy to twice-daily, controlled-release carbamazepine in newly diagnosed adults with partial-onset seizures. Primary endpoint of the trial was the proportion of patients who were seizure free for the 26-week evaluation period. Results of the trial demonstrated a similar tolerability profile of the two therapy options.