EMA approval for Zebinix®

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Bial and Eisai have announced that the European Medicines Agency (EMA) has approved Zebinix® (eslicarbazepine acetate) for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy.

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.

This marketing authorisation is based on results from a Phase III, randomised, double-blind, active-controlled, non-inferiority study (Study 311) which compared once-daily eslicarbazepine acetate as monotherapy to twice-daily, controlled-release carbamazepine in newly diagnosed adults with partial-onset seizures.

The primary endpoint was the proportion of patients seizure-free for the entire 26-week evaluation period.

The data show that 71.1% of patients for eslicarbazepine acetate and 75.6% of patients for controlled-release carbamazepine were seizure-free for six months or more, at the last evaluated dose. The one-year seizure-freedom rate at the last evaluated dose was 64.7% on eslicarbazepine acetate and 70.3% on controlled-release carbamazepine.

Epilepsy is a chronic disorder of the brain and one of the most common neurological conditions worldwide.

Eugen Trinka, Professor and Chair of Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria, said: “This approval brings the promise of a new monotherapy option for over half of patients with epilepsy who experience partial-onset seizures.”

A safety analysis of the Phase III study showed that the tolerability profile of eslicarbazepine acetate was similar to that of twice-daily controlled-release carbamazepine.