European Commission Grants Marketing Authorisation for Zebinix® (eslicarbazepine acetate) for the Treatment of Partial-Onset Seizures in Children

Porto, Portugal and Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

The European Commission extended the Marketing Authorisation for
Zebinix® (eslicarbazepine acetate) as a once-daily adjunctive
treatment for patients aged above six years with partial-onset
(focal) seizures with or without secondary generalisation.[1]

Eslicarbazepine acetate was previously indicated only for the
adjunctive treatment of adults aged over 18 with partial-onset
seizures with or without secondary generalisation.[2]

The variation to the license is based on data from one Phase III
study (305), one Phase II study (208) and from population PK
modelling and exposure-efficacy analyses. The Commission considered
the efficacy results from the mentioned studies to be acceptable for
an extension of the Marketing Authorization. The safety analyses show
no new or unexpected safety findings and eslicarbazepine acetate does
not appear to have negative neurocognitive consequences (power of
attention, information processing and working memory).[1],[3]

"We welcome the decision of the European Commission to extend the
licence for once daily eslicarbazepine acetate to paediatric
patients. Bial has an ongoing commitment to all people living with
epilepsy and this important milestone reinforces this commitment, as
well as the company's mission to care for the health of people
worldwide," comments António Portela, CEO, Bial.

"We are pleased to be able to offer the paediatric neurology
community a new treatment option to consider when caring for children
aged above six years and adolescents with partial onset seizures.
Eisai recognise the importance of delivering new clinical treatments
in this particular group of patients," comments Neil West, Vice
President, Global Neurology Business Unit, Eisai.

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.[4]

Further, eslicarbazepine acetate does not inhibit potassium
efflux, which may reduce the potential for repetitive neuronal
firings.[5] The efficacy of eslicarbazepine acetate in adult patients
was demonstrated in an initial proof-of-concept phase II study[6] and
three subsequent phase III randomised, placebo controlled studies in
1,049 people with refractory partial-onset seizures.[7],[8],[9]