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Published on 4 August 2014

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First-in-class epilepsy treatment launches in Belgium

Fycompa® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has been launched in Belgium.
The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.(1)

Fycompa® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has been launched in Belgium.
The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.(1)

Only licensed anti-epileptic drug
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain that plays a critical role in the spread of seizures.(2) This mechanism of action is different to other currently available AEDs.
In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime(1) and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch.
Epilepsy is one of the most common neurological conditions in the world.(3) In Belgium, approximately 60,000 people live with epilepsy and 150,000 people will experience an epileptic episode at some point in their life.(4) The successful treatment of partial onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20–40% of patients with newly diagnosed epilepsy will become refractory to treatment.(5)
“We are delighted to announce the launch of perampanel in Belgium. As an emerging leader in the field of epilepsy, Eisai is committed to developing innovative therapies to meet the unmet needs of people with epilepsy who need alternative treatment options to help them achieve seizure control,” commented Dr Nicolas Kormoss, Medical Director for Belgium and Luxemburg at Eisai EMEA.

Perampanel’s approval is based on three studies
Perampanel’s reimbursement approval in Belgium is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal phase III studies (304, 305, 306)(6–8) and an open-label extension study (307).(9) The three global pivotal studies show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.(6–8) Results from the open-label extension study also demonstrate perampanel’s efficacy and favourable tolerability profile over the longer term.(9)
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012.
The launch of perampanel in Belgium underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.

References

1. Fycompa, Summary of Product Characteristics (updated November 2013): http://www.medicines.org.uk/emc/medicine/26951/ (accessed 4 August 2014).

2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56–63.

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at: http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (accessed July 2014).

4. Les épilepsies – Statistiques en Belgique. Ligue Francophone Belge contre L’Epilepsie. Available at: http://www.ligueepilepsie.be/spip.php?rubrique33  (accessed July 2014).

5. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007;48 (Suppl. 1):3–7.

6. French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589–96.

7. French JA et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2013;54(1):117–25.

8. Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012;78(18):1408–15.

9. Krauss GL et al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalised seizures: Results from Phase III extension study 307. Epilepsia 2014;55: 1058–68.



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