First-in-class Epilepsy Treatment Fycompa® (Perampanel) Launches In Portugal

HATFIELD, England, August 2, 2015 /PRNewswire/ --

PRESS RELEASE FOR EU MEDICAL MEDIA ONLY: NOT FOR AUSTRIA/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), launches today in Portugal. The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondary 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, and in Europe approximately six million people live with the condition.^[3] The successful treatment of partial onset seizures remains a significant challenge in some patients and the incidence of uncontrolled partial epilepsy remains high despite the existence of many AEDs. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.^[4]

"New treatment options like perampanel are very important for people with partial onset epilepsy in Portugal who live with uncontrolled seizures. Epilepsy remains a challenging condition to treat and new treatment options with a different mode of action are welcomed by doctors." comments Nuno Canas, Department of Neurology, Hospital Egas Moniz.

Perampanel's launch in Portugal is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306)^[5],[6],[7] and an open extension study (307)^[8]. 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 generalised seizures. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.^[6],[7],[8] Results from the open extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.^[9]

The launch of perampanel in Portugal 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. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.

Notes to Editors 

About Fycompa^® (perampanel) 

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 six million people in Europe, and an estimated 50 million people worldwide.^[9],[10] 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 secondary 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 generalised seziures, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalised, in adults, adolescents and children aged six years and above. (Zonegran is under license from the originator company Dainippon Sumitomo Pharma).

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 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 September 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 July 2015)  

4. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007: 48 (Suppl1) 3 - 7 

5. French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589-596 

6. 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 

7. Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012:78(18):1408-1415 

8. 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 

9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed July 2015) 

10. 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: August 2015 

Job code: Perampanel-UK2187