First-in-class Epilepsy Treatment Fycompa® (Perampanel) Launches in Italy for Most Common Form of Epilepsy

HATFIELD, England, May 11, 2015 /PRNewswire/ --

PRESS RELEASE FOR UK AND ITALIAN MEDICAL MEDIA ONLY 

Fycompa^® (perampanel), a new class of drugs for partial onset seizures (the most common form of epilepsy), is now available in Italy. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.^[1]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively, non-competitively, target AMPA receptors, a type of receptor that plays a critical role in the onset and spread of seizures.^[2] Perampanel also has the added benefit of convenient, once-daily dosing and has the potential to be used from the age of 12 years.

Epilepsy is one of the most common neurological conditions in the world.^[3] In Italy, approximately 300,000 people live with epilepsy and 25,000 new cases are diagnosed each year.^[4] The therapeutic efficiency of AEDs in partial onset seizures remains a significant challenge for people with uncontrolled partial epilepsy refractory to AEDs already on the market. Currently, between 20-40% of people with newly diagnosed epilepsy can become refractory to available treatments.^[5]

"In the treatment of epilepsy with focal (partial onset) seizures, people often have to undergo multiple treatments before they achieve optimal control of seizures. The availability of new, effective treatments such as perampanel is certainly welcomed by both the medical profession and by people with epilepsy," comments Giuliano Avanzini, Emeritus Professor of Neurology, Fondazione IRRCS Istituto Neurologico Carlo Besta, Italy.

Perampanel was assessed in three randomised, double-blind, placebo-controlled, global Phase III studies (studies 304, 305, 306)^[6],[7],[8] and an open-label extension study (study 307).^[9] The three pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation. Perampanel was generally well tolerated, commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.^[6],[7],[8] Results from the open-label extension study also demonstrate perampanel's efficacy and favourable tolerability profile over the longer term.^[9]

"We are delighted to announce the launch of perampanel in Italy. People with epilepsy have always been our priority and we are certain that the availability of perampanel provides doctors with a new treatment option with the possibility of tailoring treatment to meet the individual needs of people with epilepsy," comments Giuseppe Lo Presti, Neurology Business Unit Director, Eisai Italy.

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 Italy 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 excessive neuronal excitability, including epilepsy neurodegenerative disorders, motor disorders, pain and psychiatric disorders.^[1]

For more information please visit: http://www.fycompa.eu  

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)**.

* Inovelon^® suspension is not currently marketed in Italy.

** The paediatric indication of Zonegran^® is not currently reimbursed in Italy.

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. Our corporate mission, which we at Eisai call our human health care (hhc) philosophy, is to "give first thought to patients and their families and to increase the benefits health care provides". 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 multiple 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. Fycompa, Summary of Product Characteristics (updated November 2014): http://www.medicines.org.uk/emc/medicine/26951/  

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 April 2015)  

4. Associazione Italiana Contro l'Epilessia. Introduzione [introduction]. http://www.aice-epilessia.it/index.php?option=com_content&view=article&id=39&Itemid=27 (Accessed April 2015) 

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 April 2015) 

11. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modelling. Epilepsia 2007:48(12):2224-2233. 

Date of preparation: May 2015 

Job code: Perampanel-UK2183