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]

Eslicarbazepine acetate is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Eslicarbazepine acetate is currently marketed in Europe and Russia by Bial and by Bial's licensee, Eisai Europe Limited, a European subsidiary of Eisai Co Ltd under the trade name Zebinix^® or Exalief^®. In the United States and Canada eslicarbazepine acetate (tradename Aptiom^®) is marketed by Sunovion Pharmaceuticals Inc under an exclusive license from Bial.

About Epilepsy   

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million people in Europe, and an estimated 50 million people worldwide.^[10],[11] Epilepsy is a chronic disorder of the brain that affects people of all ages, and is a common neurological disorder in childhood, with approximately 100,000 children and adolescents diagnosed every year.^[12] It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

About Bial   

Founded in 1924, Bial's mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, Bial has strategically focused on quality, innovation and internationalisation.

Being the partner of choice for many pharma companies, Bial is strongly committed to therapeutic innovation, investing more than 20% of its turnover in Research and Development (R&D) every year.

Bial has established an ambitious R&D programme centred in neurosciences, cardiovascular system and allergic immunotherapy. The company expects to continue to introduce new medicines and vaccines to the market in the next years, strengthening its position worldwide and accomplishing the company's purpose of "Caring for your Health."

For more information about Bial, please visit http://www.bial.com

About Eisai Co Ltd   

Eisai Co Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co Ltd, please visit http://www.eisai.com

References

1.  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
2.  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
3.  Moreira J, et al. J Neurol Sci 2015;357:e432-456 (abstract 1513; WFN15-1735; e439)
4.  Hebeisen S, et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015; 89:122-35
5.  Soares-da-Silva P, et al. Eslicarbazepine acetate for the treatment of focal epilepsy: an update on its proposed mechanisms of action. Pharmacol Res Perspect. 2015; 3:e00124
6.  Elger C, et al. Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia 2007; 48:497-504
7.  Elger C, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50:454-63
8.  Ben-Menachem E, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85
9.  Gil-Nagel A, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in  adults with refractory partial-onset seizures. Acta Neurol Scand. 2009; 120:281-87
10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf  Accessed November 2016
11. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-33
12. Forsgren L, et al. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005; 12(4):245-53

December 2016

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