HATFIELD, England, November 6, 2014 /PRNewswire/ --
Eisai announces with utmost disappointment that the German Federal Joint Committee (G-BA) has decided that the additional benefit for new generation anti-epileptic drug (AED) Fycompa® (perampanel) has not been proven, when compared to conventional AEDs as defined by the G-BA. The decision, based on methodological rather than clinical considerations, ignores the demands of the German Epilepsy Association (DE) and other epilepsy patient advocacy groups to recognise the additional benefit seen in practical applications as well as in studies. The decision also ignores the recommendations of the German Society of Epileptology (DGfE) to assess the additional benefit of new AEDs.
The efficacy and tolerability of adjunctive perampanel in the treatment of partial onset seizures in real world clinical practice has been demonstrated by a multi-centre, six-month observational study from nine epilepsy centres in Germany and Austria. The results show that half of the 281 people with highly refractory epilepsy treated with perampanel experienced at least a 50% reduction in seizure frequency and up to 15% became seizure free during the observation period. "We are utterly disappointed by the decision of the German Joint Federal Committee (G-BA) not to recognise the additional benefit of perampanel and are totally unable to understand their reasons. It has been demonstrated that there are patients who experience significantly fewer seizures or have even become seizure-free on Fycompa. With this decision, the G-BA is denying people with epilepsy for whom no current treatment has been successful, the benefits of medical progress," said Stefan Conrad, President of the German Epilepsy Association.
Perampanel is the first and only licensed AED to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures. This mechanism of action is different to all other, currently available AEDs. In addition, perampanel has the advantage of convenient, once-daily dosing at bedtime and significantly, since its launch, is the only new-generation partial epilepsy treatment approved to treat adolescents (12 years and older) with epilepsy. Perampanel is available in more than 35 countries worldwide.
"To ignore the considerable real world experience data available in Germany for perampanel is a mistake. As a clinician, I understand the impact that epilepsy can have on people and their families and the importance of being able to access new treatment options. I have personally observed the potential of perampanel for my long-time refractory epilepsy patients and hoped that the G-BA would also recognise this potential," commented Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany.
Epilepsy is one of the most common neurological conditions in the world and over half a million people in Germany live with the condition. The successful treatment of partial onset seizures remains a challenge; up to a third of people with epilepsy do not achieve seizure freedom despite appropriate therapy with AEDs.
"We are dismayed by the G-BA's decision and what appears to be the lack of consideration displayed for the some 4,000 people in Germany with epilepsy who have already benefited from the treatment with perampanel. All European countries show a flexible, patient-oriented approach to their decision making process, but on this occasion the stringent German system has failed to listen to the patients it should help and the clinical experts treating people with refractory epilepsy. We will strive to continue talks with the G-BA to find a solution for the people who depend on new epilepsy treatments such as perampanel," commented Gary Hendler, President & CEO, Eisai EMEA.
Perampanel was approved by the European Commission in 2012 and 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. Eisai submitted a Marketing Authorisation Application to the European Commission for perampanel as an adjunctive treatment of primary generalised tonic-clonic seizures (PGTC) in August 2014.
Eisai is committed to the therapeutic area of epilepsy and to addressing the unmet medical needs of people with epilepsy and their families, an integral part of our human health care (hhc) mission. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
Notes to Editors
About Fycompa® (perampanel)
Perampanel 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.
Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.
About Perampanel in Germany
The first multicentre, real world experience with perampanel in a larger series of consecutive patients with difficult-to-treat epilepsy from nine specialised hospitals from Germany (seven centers) and Austria (two centers) has been published in Epilepsy Research. Patients (54% female, mean age 39 years) were followed-up for treatment outcome for a minimum of six months. In half of the 281 patients included, who received perampanel mostly as an add-on to a baseline therapy consisting of two or three AEDs (65%), seizure frequency was reduced by at least 50%. Seizure freedom was achieved in 15% of patients. Adverse events were reported by 52% of patients, with somnolence (24.6%) and dizziness (19.6%) being most frequently reported. The retention rate after six months was 60%. The mean perampanel dosage was 7.7 mg. In some patients, a marked response could be observed at relatively low dosages.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide., Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
About Primary Generalised Tonic-Clonic Seizures
Generalised tonic-clonic seizures are one of the most dangerous types of seizure. For the majority of patients, a primary generalised tonic-clonic (PGTC) seizure begins with a loss of consciousness without any prior warning symptoms and a sudden tonic contraction of the muscles, causing the patient to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax, and the patient is left with a disturbance of consciousness. As this is a serious event, it is seen as a major hindrance on daily life. While the seizure generally only lasts a few minutes, the patient will often feel confused or drowsy for a short period of time before returning to normal.
About Eisai EMEA in Epilepsy
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia, Commonwealth of Independent States and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
- Zonegran® (zonisamide) as monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without generalisation, in adults, adolescents and children aged six years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
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 various 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 http://www.eisai.com.
1. G-BA assessment dossier. Available at: https://www.g-ba.de/informationen/beschluesse/2091/ Accessed: November 2014
2. German Epilepsy Association (DE). Opinion of epilepsy self-help associations in Germany to benefit assessment of antiepileptic Fycompa® (active ingredient: perampanel) by the Institute for Quality and Efficiency in Health Care (IQWiG) from 08.15.2014. Available at: http://www.epilepsie-vereinigung.de/2014/09/stellungnahme-der-epilepsie-selbsthilfeverbaende-deutschland/ Accessed: October 2014
3. Steinhoff BJ et al. A multicentre survey of clinical experiences with perampanel in real life in Germany and
Austria. Epilepsy Res 2014:108(5):986-988
4. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011:11:56-63
5. Fycompa, Summary of Product Characteristics (updated September 2014): http://www.medicines.org.uk/emc/medicine/26951/
6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at: http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf Accessed: October 2014
7. Pfäfflin, M. Epidemiologie der Epilepsien. Available at: http//www.izepilepsie.de/home/showdoc.id.387.aid.4163.html Accessed: October 2014
8. Schmidt D. Drug treatment of epilepsy: options and limitations. Epilepsy & Behavior 2009:15:56-65
9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf Accessed: October 2014
10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233
11. Blumenfeld H et al. Cortical and subcortical networks in human secondarily generalized tonic-clonic seizures. Brain. 2009:132:999-1012
12. Epilepsy Action. Generalised seizures. https://www.epilepsy.org.uk/info/seizures/generalised-seizures (accessed July 2014)
Date of preparation: November 2014
Job code: Perampanel-UK2179
SOURCE Eisai Europe Limited