Zebinix® (eslicarbazepine acetate) Receives Positive CHMP Opinion as Once-daily Monotherapy for Newly Diagnosed Focal-onset Epilepsy - Seite 2

"This CHMP decision, with the promise it brings of a new treatment option for patients is very welcome. Around 60 per cent of patients with epilepsy have focal seizures, and we also know that adherence to treatment is better with a once-daily monotherapy." explains Eugen Trinka, Professor and Chair of Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.

"This is important news for people with focal epilepsy who may now be able to benefit from a once-daily monotherapy treatment as soon as they are diagnosed. It is a relevant milestone in the development program of eslicarbazepine acetate and we are delighted that we may now be able to offer this treatment option for patients with focal epilepsy across Europe," comments António Portela, CEO of Bial, Porto, Portugal.

A safety analysis^[2] of the same study showed the side effects of eslicarbazepine acetate were mostly of mild intensity, and consistent with the known safety profile. Incidence rates of treatment emergent adverse events (TEAEs) were similar but slightly higher in patients receiving controlled-release carbamazepine (77.7%) (n=320) versus eslicarbazepine acetate (75.3%) (n=302). Possibly-related TEAEs were also slightly higher at 49.5% (n=204) for controlled-release carbamazepine compared with 41.1% (n=165) for eslicarbazepine acetate, for serious possibly-related TEAEs (2.7% vs 2.0%) (n=11 vs n=8), and for TEAEs leading to withdrawal (18.0% vs 13.5%) (n=74 vs n=54). The most frequently reported possibly-related TEAEs for eslicarbazepine acetate were headache, dizziness, nausea, fatigue, and somnolence.^[2]

"This positive opinion from the CHMP reinforces Eisai's commitment to researching and developing neurological treatment options that have the potential to help people manage their condition. We are pleased that this decision means patients in Europe who experience epilepsy will have a broader range of treatment options available," comments Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.

The continued development of eslicarbazepine acetate underscores Bial's and Eisai's commitment to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy.

Notes to Editors 

About Zebinix^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel (which have been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.^[5] Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings.^[6] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study^[7] and three subsequent phase III randomised, placebo controlled studies in 1,049 people with refractory partial onset seizures.^[8],[9],[10]