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The UK pharmaceutical regulatory body, the National Institute for Health and Clinical Excellence (NICE), has issued a Final Appraisal Determination (FAD), recommending retigabine as an option for the adjunctive (add-on) treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy, when previous treatment with other anti-epilepsy drugs (AEDs) has not provided an adequate response, or has not been tolerated. These epilepsy treatments are commonly prescribed as initial monotherapy or used in combination.
Epilepsy is a common, chronic disabling neurological condition which affects people of all ages. It is characterised by recurrent epileptic seizures, occurring when there is abnormal and/or excessive neuronal activity in the brain.
Of those people diagnosed with epilepsy in the UK, around 30% do not respond to initial epilepsy treatments and remain uncontrolled. This group is considered refractory 2 and equates to approximately 60,000 people in the UK.
Refractory epilepsy has a negative impact on the quality of the lives of patients with the disorder. A 2008 review by Jacoby et al concluded that having active epilepsy can profoundly affect the quality of life (QoL) of patients with the condition. Refractory epilepsy is also associated with an increased risk of sudden death and significant costs to society and to the healthcare system.
Retigabine is the first in a new class of epilepsy treatments and is currently the only AED to target neuronal potassium channels which are involved in inhibitory mechanisms in the brain, and are thought to have a role in seizure control. The efficacy and safety of retigabine was established in two pivotal multicentre, randomised, double-blind, placebo-controlled, fixed dose studies.
The NICE recommendation of retigabine will offer patients and clinicians an additional option for difficult to control epilepsy.
“Epilepsy is a highly individual and complex condition which, for a significant percentage of people is difficult to control. Many individuals live with seizures on a regular basis for years despite having had many of the currently available treatments. We have seen that with perseverance, it is possible to improve seizure control and thus the quality of life of people in this group. A drug with a new mode of action, could provide an important new option for people whose lives are blighted by seizures not controlled by their current treatment,” said Dr Ley Sander, Professor of Neurology at UCL Institute of Neurology.
Mark Toms, Medical Director, Neurology, GlaxoSmithKline (GSK) UK commented: “In retigabine we believe we have a new option for people with refractory partial onset epilepsy. This is a patient group, who live with a high level of uncertainty around when and where a seizure might happen. We are delighted that NICE has recognised retigabine as an additional adjunctive treatment option and will continue to actively engage with the NICE process until completion.”