EC grants Marketing Authorisation for Zebinix® for the treatment of partial-onset seizures in children

Posted in Industry News on 10th Mar 2017

 

The European Commission (EC) has 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.[i]

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

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 Authorisation. The safety analyses show no new or unexpected safety ndings and eslicarbazepine acetate does not appear to have negative neurocognitive consequences (power of attention, information processing and working memory).[iii]

References

[i] European Commission: Community register of medicinal products for human use. Product Information – Zebinix. Available at: http://ec.europa.eu/health/documents/community- register/html/h514.htm Last updated December 2016
[ii] Zebinix SMPC, Available at http://www.ema.europa.eu/docs/en_GB/document_library/ EPAR_-_Product_Information/human/000988/WC500047225.pdf Last updated: May 2016
[iii] Moreira J, et al. J Neurol Sci 2015;357:e432–456 (abstract 1513; WFN15-1735; e439)

Published online: 14/3/17