New European real-world audit data provides additional information on the effectiveness of Zebinix® (eslicarbazepine acetate) for the treatment of partial-onset epilepsy in adults

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

- Results from the pooled analysis presented at the American Epilepsy
Society Annual Meeting 2017 in Washington DC, US.[1],[2],[3]

Bial and Eisai have announced new real-world audit data presented
at the American Epilepsy Society (AES) Annual Meeting 2017, which add
to the existing clinical trials examining the effectiveness and
tolerability of Zebinix® (eslicarbazepine acetate). These data assess
the real-world effectiveness, safety and tolerability of
eslicarbazepine acetate when used as monotherapy in patients with
partial-onset seizures, following conversion from previous treatment
with carbamazepine or oxcarbazepine and when treated with <=1200 or
>1200 mg/day eslicarbazepine acetate.[1],[2],[3]

Euro-Esli, an exploratory pooled analysis of data from 14 European
clinical practice studies including 2,058 patients aged 14-88 years
old with partial-onset seizures (POS), with or without secondary
generalization, examined the real world use of eslicarbazepine
acetate as monotherapy, as well as adjunctive therapy, for POS in
clinical practice.

"Euro-Esli study offered data of >200 patients with
eslicarbazepine acetate in monotherapy, where it proved to be an
effective and tolerable option," says Dr Vicente Villanueva,
Neurologist and Epileptologist, Hospital Universitario y Politécnico
La Fe, Valencia, Spain.

The Euro-Esli study also showed that eslicarbazepine acetate was
efficacious and generally well tolerated in patients switching from
carbamazepine or oxcarbazepine in clinical practice.[1] A further
abstract, examining a different Euro-Esli data set, explored the
effectiveness, safety and tolerability of eslicarbazepine acetate in
patients with partial-onset seizures treated with <=1200 or >1200
mg/day.[2]

Epilepsy is one of the most common neurological conditions in the
world, affecting approximately fifty million people in Europe. [4] It
is defined as either: (1) the occurrence of two or more unprovoked
seizures >24 hours apart; (2) one unprovoked (or reflex) seizure and
a probability of further seizures occurring over the next 10 years
that is similar to the general recurrence risk (at least 60%) after
two unprovoked seizures; (3) diagnosis of an epilepsy syndrome.[5]
Depending on the type, seizures may involve one part of the body or
the whole body, and may affect consciousness. Epilepsy has many
possible causes but sometimes the cause is unknown.[6]

"Real-world data explores the impact of a treatment in a real-life
environment and these data improve our knowledge and understanding
around the use of eslicarbazepine acetate, reinforcing BIAL's
commitment to developing and delivering beneficial treatment options
for people living with epilepsy." comments António Portela, CEO of
BIAL.

"We are committed to the development of our anti-epileptic drug
product portfolio, and Eisai continues to invest in real world
evidence which will help us ensure we are addressing the diversity of
epilepsy patients, which may help improve their quality of life,"
comments Neil West, Vice President EMEA, Global Neurology Business
Unit at Eisai.

In Europe eslicarbazepine acetate is indicated as:

- monotherapy in the treatment of partial-onset seizures, with or
without secondary generalisation, in adults with newly diagnosed
epilepsy;
- adjunctive therapy in adults, adolescents and children aged above 6
years, with partial-onset seizures with or without secondary
generalisation.[7]

Notes to Editors

About the Euro-Esli study[1],[2],[3]

Euro-Esli was a pooled analysis of 14 European clinical practice
studies. Effectiveness assessments included responder rate (>=50%
seizure frequency reduction) and seizure freedom rate (seizure
freedom at least since prior visit), assessed after 3, 6 and 12
months of ESL treatment, and at last visit. Safety and tolerability
were assessed throughout follow-up by evaluating adverse events (AEs)
and ESL discontinuation due to AEs, respectively.

Monotherapy in clinical practice[3]

Data were compared for patients treated initially with ESL
monotherapy versus adjunctive therapy, and for patients treated at
last visit with ESL monotherapy versus adjunctive therapy.

Of the 2058 patients included in Euro-Esli (mean age 44.0 years;
52.1% male), the number of concomitant AEDs used at baseline and last
visit was known for 2045 and 1340 patients, respectively. ESL was
used as monotherapy in 88/2045 (4.3%) patients initially and in
229/1340 (17.1%) patients at last visit. At 12 months, responder and
seizure freedom rates were significantly higher in patients treated
initially with ESL monotherapy versus adjunctive therapy, and in
patients treated at last visit with ESL monotherapy versus adjunctive
therapy. The overall incidence of AEs was similar in patients treated
initially with ESL monotherapy and adjunctive therapy, and in
patients treated at last visit with ESL monotherapy and adjunctive
therapy. The rate of discontinuation due to AEs was not significantly
different in patients treated initially with ESL monotherapy versus
adjunctive therapy, but the rate was significantly lower in patients
treated at last visit with ESL monotherapy versus adjunctive therapy.

Transitioning from carbamazepine or oxcarbazepine in everyday
clinical practice[1]

Data were analysed for cohorts of patients who transitioned from
carbamazepine or oxcarbazepine to ESL either due to, in most of the
cases, lack of efficacy or poor tolerability.

Euro-Esli included 2058 patients (52.1% male; mean age, 44 years;
mean duration of epilepsy, 20.9 years), of whom 233 (11.3%)
transitioned from carbamazepine to ESL and 134 (6.5%) transitioned
from oxcarbazepine to ESL. After 12 months of ESL treatment,
responder and seizure freedom rates for patients transitioning from
carbamazepine due to lack of efficacy (n=163) were 70.0% and 30.9%,
respectively. Corresponding values for patients transitioning from
oxcarbazepine due to lack of efficacy (n=90) were 57.1% and 25.0%,
respectively. Among patients who transitioned from carbamazepine and
oxcarbazepine to ESL due to lack of efficacy, 11.6% and 10.5%
discontinued ESL due to lack of efficacy, respectively. Among
patients who transitioned from carbamazepine and oxcarbazepine to ESL
due to poor tolerability (n=64 and n=61, respectively), 26.6% and
39.5% experienced AEs, and 8.3% and 6.8% discontinued ESL due to AEs,
respectively.

Doses >1200 mg/day versus <=1200 mg/day[2]

Data were compared for patients who were treated at any time
during follow-up with ESL at a dose >1200 mg/day vs those who were
only treated with ESL at doses <=1200 mg/day.

Of the 2058 patients included in Euro-Esli (mean age 44.0 years;
52.1% male), information on ESL dosing was known for 1920 patients.
Among these patients, 1749 (91.1%) were treated with ESL <=1200
mg/day and 171 (8.9%) were treated with ESL >1200 mg/day. The number
of prior antiepileptic drugs used was significantly lower in patients
treated with ESL <=1200 vs >1200 mg/day (median, 3 vs 4; mean, 4 vs
5; p<0.001; Mann-Whitney test). At all timepoints, responder and
seizure freedom rates were significantly higher in patients treated
with ESL <=1200 mg/day than in those treated with ESL >1200 mg/day.
The overall incidence of AEs was significantly higher in patients
treated with ESL <=1200 mg/day vs >1200 mg/day (34.8% vs 22.8%;
2=9.91; p=0.002; Chi-squared test). Similarly, the rate of ESL
discontinuation due to AEs was significantly higher in patients
treated with ESL <=1200 mg/day vs >1200 mg/day (14.7% vs 6.1%;
2=9.27; p=0.002; Chi-squared test).

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.[8] The efficacy of eslicarbazepine acetate was
demonstrated in an initial proof-of-concept phase II study[9] and
three subsequent phase III randomised, placebo controlled studies in
1,049 people with refractory partial-onset seizures.[10],[11],[12]

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. Peltola J, McMurray R, Villanueva V. (2017) Efficacy, safety
and tolerability of eslicarbazepine acetate in patients transitioning
from carbamazepine or oxcarbazepine in everyday clinical practice.
American Epilepsy Society Annual Meeting (AES) 2017; Washington, US.
Abst. 1.319.

2. Villanueva V, McMurray R. (2017) Effectiveness, safety and
tolerability of eslicarbazepine acetate at doses >1200 mg/day versus
<=1200 mg/day: real-world evidence from the Euro-Esli study. American
Epilepsy Society Annual Meeting (AES) 2017; Washington, US. Abst.
1.318.

3. McMurray R, Villanueva V, Delanty R. (2017) Real-world data on
the effectiveness, safety and tolerability of eslicarbazepine acetate
monotherapy in clinical practice. American Epilepsy Society Annual
Meeting (AES) 2017; Washington, US. Abst. 2.313.

4. Saxena S, et al. (2017) Defeating epilepsy: A global public
health commitment. Epilepsia Open. 2 (2), 153-155.

5. Fisher, R.S., et al. (2014) ILAE Official Report: A practical
clinical definition of epilepsy. Epilepsia. 55(4), 475-482.

6. Laxer D, et al. (2014) The consequences of refractory epilepsy
and its treatment. Epilepsy & Behaviour. 37, 59-70.

7. Eisai. (2017) Zebinix® (eslicarbazepine acetate) Summary of
Product Characteristics. Available from:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/000988/WC500047225.pdf. [Accessed October 2017].

8. 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

9. 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.

10. 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.

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

12. 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.

December 2017

Zebinix-EU0153

ots Originaltext: Eisai
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Bial
Susana Vasconcelos
Susana.vasconcelos@bial.com

Eisai
Helena Symeou
+44 7505 309 895
Helena_Symeou@eisai.net

Tonic Life Communications
Chrissie Hannah
+44 777 253 4646
chrissie.Hannah@toniclc.com

Original-Content von: Eisai, übermittelt durch news aktuell