1551 0 Kommentare European Commission Grants Marketing Authorisation for Zebinix® (eslicarbazepine acetate) for the Treatment of Partial-Onset Seizures in Children

PORTO, Portugal and HATFIELD, England, December 19, 2016 /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]