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Scottish Medicines Consortium Approves Zebinix - Once Daily Anti-Epileptic Treatment


11/9/2010 1:12:13 PM

November 8, 2010 -- Zebinix® (eslicarbazepine acetate), a treatment for epilepsy, has been accepted for restricted use in Scotland after a decision by The Scottish Medicines Consortium (SMC).1 Following the new clinical and cost effectiveness decision, Zebinix can now be used as an add-on (adjunctive) therapy in adults with partial-onset seizures, with or without secondary generalisation (where the seizure spreads to both sides of the brain). The Committee adds that Zebinix use should be restricted to patients with hard-to-treat (highly refractory) epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs, contingent upon the continuing availability of the patient access scheme in Scotland.

Epilepsy is one of the most common neurological diseases, affecting nearly 40,000 people in Scotland 2 – and the successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge. Up to 40% of patients with partial seizures do not achieve seizure control with current treatments.3

“Being able to adequately control seizures is a continual challenge for doctors looking after people with epilepsy. Uncontrolled seizures place a huge burden on patients and their families and are associated with poor quality of life, reduced likelihood of employment and an increased risk of psychological comorbodities such as depression and anxiety. Today’s recommendation by the SMC to make Zebinix available in Scotland is a very welcome decision – it gives physicians another string to their therapeutic bow and people with epilepsy the possibility of improved seizure control,” commented Martin Brodie, Professor of Medicine and Clinical Pharmacology at the University of Glasgow and Director, Epilepsy Unit, Western Infirmary, Glasgow.

Zebinix was approved for use by the European Medicines Agency in April 2009 for the treatment of adults with partial-onset seizures with or without secondary generalisation.4 In its first year Zebinix has had over 9,000 months of patient exposure.5

For further information please contact:

Benjamyn Tan / Helen Swift Tonic Life Communications +44 (0) 20 7798 9923 / +44 (0) 20 7798 9924 benjamyn.tan@toniclc.com / helen.swift@toniclc.com

Eisai Europe Ltd - Cressida Robson: +44 (0) 845 676 5318

References

1) Scottish Medical Consortium advice on Zebinix available at: http://www.scottishmedicines.org.uk/Home

2) Epilepsy Scotland available at: http://www.epilepsyscotland.org.uk/ (Accessed 01 November 2010).

3) Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342: 314-9.

4) European Medicines Agency. Zebinix (eslicarbazepine acetate): summary of product characteristics. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000988/WC500047226.pdf (Accessed 2 November 2010)

5) Eisai Europe Ltd. Data on file.


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