Briviact® launches in the UK, offering a new option for patients with uncontrolled epilepsy

Briviact^® (brivaracetam), a new add-on treatment for adults with epilepsy (aged 16 years and older) with partial–onset seizures (POS), with or without secondary generalised seizures, now available on the NHS.¹

Epilepsy is the world’s most common serious neurological illness, affecting about 600,000 people in the UK. However it is not always controlled by medication,^2,3 putting patients at risk of serious injury and even death (Sudden Unexpected Death in Epilepsy).⁴

UCB announced that Briviact^® (brivaracetam) has been authorised as an add-on treatment for partial onset seizures (POS), with or without secondary generalised seizures (spreading from one side to both sides of the brain after the initial seizure), in adults with epilepsy (aged 16 years and older). Brivaracetam is an anti-epileptic drug (AED) that provides patients, with this particular type of epilepsy, a new opportunity to better manage their seizures.¹

In an international Phase III study of 768 patients uncontrolled on their previous medication, at 50mg dose twice daily against placebo, Brivaracetam was shown to give significant seizure freedom compared with the patients’ usual medication.⁵ Patients also revealed the importance of reducing the titration period – 51% of patients who participated in an independent European treatment satisfaction survey said this was an important goal. Brivaracetam has no up titration period.⁶ The Brivaracetam clinical trials programme was one of the largest in epilepsy, with more than 3000 patients taking part.⁷

Dr Mark Manford, Consultant Neurologist at Bedford and Addenbrookes Hospitals said: “Finding the right combination of medicines for many epilepsy patients can be a long journey, during which time the patient may continue to suffer seizures and living a normal life is very difficult. As a neurologist working with patients whose seizures have not yet been brought under control, I welcome the possibility that a new medicine may be able to contribute to the tools available to help my patients.”

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There are currently 600,000 (or one in 100) people with epilepsy in the UK and the number of cases is increasing partly as a result of the ageing population.^2,8 Unfortunately, only 52% of people treated for epilepsy are seizure-free but that figure could rise to 70% with the right treatment.³ 10% of all A&E admissions are for convulsions and seizures, but less than half of these patients are referred to a specialist and many may also not be receiving the optimal treatment for their epilepsy.⁹

Seizures, which often occur without warning, make it difficult for patients to lead a normal life, as well as hold down a job and relationships. The economic cost of epilepsy in England & Wales is estimated at £2 billion annually, 69% of which is due to indirect costs such as unemployment and mortality.¹⁰

Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “Seizures can have a significant impact on people’s lives and wellbeing so it’s really important that those with epilepsy can access the best possible treatment to help them enjoy life to the full. It is always encouraging to see the creation of new medicines for people with epilepsy. Brivaracetam could be an effective treatment for those people with epilepsy who have so far struggled to become seizure free.”

John-Kenneth Sake, Head Medical Affairs Central Nervous System Europe, UCB said: “We are delighted to offer an alternative treatment to epilepsy patients who are having difficulties in controlling their seizures. UCB has been committed to the management of epilepsy, working very closely with patients through all stages of development to ensure a better understanding of the unmet needs of those suffering from this severe and life-changing condition. We hope that the launch of brivaracetam will help many epilepsy patients in the UK and across Europe.”

Brivaracetam was granted European Medicines Agency (EMA) authorisation for use within Europe and the UK on 14 January 2016, specifically for the treatment of POS, with or without generalised seizures.¹

References:

1. European Medicines Agency marketing authorisation http://www.ncbi.nlm.nih.gov/pubmed/23219031. Accessed January 2016
2. Epilepsy Action. Epilepsy facts, figures and terminology. Available at: https://www.epilepsy.org.uk/press/facts. Accessed January 2016
3. Nursing Times. Available at: http://www.nursingtimes.net/clinical-subjects/neurology/identifying-and-managing-epilepsy-in-older-adults/5053730.fullarticle. Accessed January 2016.
4. Sudden Death in Epilepsy. Epilepsy Society http://www.epilepsysociety.org.uk/sudep#.VpE-gU3MWpo. Accessed January 2016.
5. Klein P et al. A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Adult Patients with Partial-Onset Seizures.
6. UCB Data on file.
7. UCB Data on file.
8. Epilepsy Research UK. Number of Epilepsy Cases Predicted to Rise. Available at: http://www.epilepsyresearch.org.uk/number-of-epilepsy-cases-predicted-to-rise/. Accessed January 2016.
9. National Audit of Seizure Management in hospital http://bmjopen.bmj.com/content/5/3/e007325. Accessed January 2016.
10. The Costs of Epilepsy Misdiagnosis in England & Wales. http://www.sciencedirect.com/science/article/pii/S1059131106001634. Accessed January 2016.
11. UCB Data on file.
12. UCB Data on file.
13. Briviact Prescribing Information.
14. Quarato P et al. Efficacy and safety of adjunctive brivaracetam for partial-onset (focal) seizures: pooled results from three fixed-dose, randomised, double-blind, placebo-controlled Phase III studies; 2015; Abstract presented at 31st International Epilepsy Congress (IEC), September 5–9, 2015; Istanbul, Turkey.
15. Epilepsy Foundation. Who gets epilepsy? Available at: http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed January 2016.
16. European Federation of Pharmaceutical Industries and Associations. Epilepsy. Available at: http://www.efpia.eu/diseases/89/59/Epilepsy. Accessed January 2016.
17. Fisher RS et al. ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia 2014;55(4):475–82.
18. Bromfield EB, Cavazos JE, Sirven JI. An Introduction to Epilepsy. US National Library of Medicine. http://www.ncbi.nlm.nih.gov/books/NBK2508/. Accessed January 2016
19. Epilepsy Foundation website. What are secondary generalized seizures. Available at: http://www.epilepsy.com/learn/types-seizures/secondarily-generalized-seizures. Accessed December 2015.