Real-world data confirms clinical effectiveness of Zebinix® (eslicarbazepine acetate) for the treatment of partial-onset epilepsy in Adults

PORTO, Portugal and HATFIELD, England, September 5, 2017 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS  

• Eslicarbazepine acetate data shows seizure freedom in 41.3% of patients at 12 months, and retention rates of 73.4%.^[1]
• Results from the Euro-Esli study will be presented today at the 32^nd International Epilepsy Congress (IEC) in Barcelona, Spain.^[1]

Bial and Eisai today announce data which confirm the effectiveness and tolerability of Zebinix^® (eslicarbazepine acetate) in routine clinical practice, thereby complementing evidence from clinical trials.^[1] The Euro-Esli study is an exploratory pooled analysis of data from 14 European clinical practice studies, analysing data of 2,058 patients aged between 14-88 years old with partial-onset seizures (POS), with or without secondary generalisation.^[1] Full results will be presented today at the IEC in Barcelona, Spain.^[1]

"It is most reassuring to see similar efficacy results with eslicarbazepine acetate in a routine clinical setting compared to that of clinical trials; we can be confident that this treatment is effective amongst the diversity of our 'real' epilepsy patients," explains Dr Vicente Villanueva, Neurologist and Epileptologist, Hospital Universitario y Politécnico La Fe, Valencia, Spain. "Real-world studies like the Euro-Esli study are important because they provide significant insight into how a drug performs in a routine medical setting, allowing us to assess the drug, to ultimately improve patient outcomes."

Epilepsy is one of the most common neurological conditions in the world, affecting approximately six million people in Europe.^[2] An epileptic seizure is a clinical manifestation of the condition, thought to result from an abnormal discharge of a set of neurons in the brain.^[2] Seizures can vary in manifestation, from brief lapses of attention to severe and prolonged convulsions.^[3] Depending on the type, seizures may involve one part of the body or the whole body, and may affect consciousness.^[3] Seizures can also vary in frequency from less than one per year, to several per day.^[3] Epilepsy has many possible causes but often the cause is unknown.^[3]

The Euro-Esli study (in over 2,000 patients with epilepsy) showed that at 3, 6 and 12 months, seizure freedom rates in patients aged 14-88 years treated with eslicarbazepine acetate were 30.6%, 38.3% and 41.3% respectively. Retention rates were 95.4%, 86.6% and 73.4% and responder rates were 60.9%, 70.5% and 75.6%, respectively.^[1] There were significant reductions from baseline to final visit in monthly frequencies of total (mean reduction 44.1%), simple partial (78.8%), complex partial (53.1%) and secondarily generalised (80.0%) seizures (p<0.001 for all).^[1] Adverse events were reported for 34.0% of patients and led to discontinuation of 13.6% of patients.^[1] The most frequently reported adverse events were dizziness (6.7%), fatigue (5.4%) and somnolence (5.1%).^[1]  

"These results improve our knowledge and understanding around the use of eslicarbazepine acetate in routine clinical practice and strengthen Bial's commitment to developing and delivering beneficial treatment options for people living with epilepsy," comments António Portela, CEO of Bial.

"These data underscore our commitment to our anti-epileptic drug product portfolio. We will continue to invest both in clinical trials and the generation of real-world evidence to improve the lives of patients living with epilepsy," comments Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.

Eslicarbazepine acetate is indicated as monotherapy in the treatment of POS, with or without secondary generalisation, in adults with newly diagnosed epilepsy; and as adjunctive therapy in adults, adolescents, and children aged above six years, with POS with or without secondary generalisation.^[4]

Notes to Editors  

About the Euro-Esli study  ^[1] 

The Euro-Esli study was a large, exploratory, pooled analysis of real-world data from 14 European clinical practice studies, including data from 2,058 patients (52.1% male; mean age 44 years; mean epilepsy duration 20.9 years). Retention and effectiveness were assessed after 3, 6 and 12 months of treatment with eslicarbazepine acetate. Effectiveness assessments comprised percentage reduction from baseline in monthly seizure frequency, responder rate (≥50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit). Safety and tolerability were assessed by evaluating adverse events (AEs).  

About Zebinix^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker, which selectively targets the slow inactivated state of the sodium ion channel.^[5] The efficacy of eslicarbazepine acetate 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 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 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.

Bial is strongly committed to therapeutic innovation, investing more than 20 per cent of its turnover in Research and Development (R&D) every year.

Bial has established an ambitious R&D program centered on the neurosciences and cardiovascular system. The company expects to introduce more new medicines to the market in the next years, strengthening its international presence based in its own innovative medicines, and accomplishing the company's purpose of "Caring for your Health."

For more information about Bial, please visit 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 www.eisai.com

References  

^[1] Villanueva V, et al. (2017) A European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures: the Euro-Esli study. International Epilepsy Congress (IEC) 2017; Barcelona, Spain, Poster p0918

^[2] World Health Organization. (2010) Epilepsy in The WHO European Region: Fostering Epilepsy Care in Europe. Cruquius, Paswerk Bedrijven. Available from: www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed August 2017].

^[3] World Health Organization. (2017) Epilepsy Fact Sheet. Available from: www.who.int/mediacentre/factsheets/fs999/en/[Accessed August 2017].

^[4] Eisai. (2017) Zebinix® (eslicarbazepine acetate) Summary of Product Characteristics. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf  [Accessed August 2017].

^[5] Hebeisen S, et al. (2015) Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: A comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 89, 122-135

^[6] Elger C, et al. (2007) Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia. 48, 497-504.

^[7] Elger C, et al. (2009) 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. 50, 454-63.

^[8] Ben-Menachem E, et al. (2010) Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Research. 89(2-3), 278-85.

^[9] Gil-Nagel A, et al. (2009) Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurologica Scandinavica. 120, 281-87.

August 2017 
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