First-in-Class Epilepsy Treatment Fycompa® (Perampanel) Launches in Australia

HATFIELD, England, November 3, 2014 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS 

Fycompa^® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has received reimbursement in Australia. It 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]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which 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 Australia it is estimated that 225,000 Australians live with epilepsy, and approximately 800,000 will be diagnosed with the condition at some stage in their life.^[4] The successful treatment of partial onset seizures remains a significant challenge in some people and the incidence of uncontrolled partial epilepsy remains high despite many AEDs. Currently, between 20-40% of people with newly diagnosed epilepsy will become refractory to treatment.^[5]

"There is an ongoing need for effective and well-tolerated treatment options for people with pharmacoresistant epilepsy, particularly as many will try a range of drugs before finding one that works for them.  Fycompa is a mechanistically unique new agent, whose launch in Australia will be welcomed by patients and their doctors," Professor Martin Brodie, Clinical and Research Director of the Epilepsy Unit at the University of Glasgow in Scotland.

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],[7],[8] Results from the open-label extension study demonstrate perampanel's efficacy and favourable tolerability profile 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 Australia 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.

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.^[1]

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.^[1]

About Epilepsy  

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.^[10],[11] 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 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 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 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.

References 

1. Australia Government, Department of Health. Pharmaceutical Benefits Scheme. Available at http://www.pbs.gov.au/pbs/home Accessed: October 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: October 2014
4. Epilepsy Action Australia. Facts and statistics about Epilepsy. Available at: http://www.epilepsy.org.au/resources/for-media/facts-statistics-about-epilepsy Accessed: October 2014
5. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3–7
6. French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589-596
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):117-125
8. Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012:78(18):1408-1415
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;55:1058-1068
10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf Accessed: October 2014
11. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia    2007:48(12):2224-2233

Date of preparation: November 2014
Job code: Perampanel-UK2177