HATFIELD, England, June 25, 2015 /PRNewswire/ --

New indication for anti-convulsant treatment to reduce serious seizures for idiopathic generalised epilepsy 

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

The European Commission (EC) has today granted marketing authorisation approval for Fycompa^® (perampanel), for use as a once-daily, adjunctive therapy for primary generalised tonic-clonic (PGTC) seizures in adults and adolescents (>12 years) with idiopathic generalised epilepsy (IGE). The number of anti-epileptic drugs (AEDs) licensed for the treatment of PGTC seizures is limited,^[1] and perampanel, the first new treatment for PGTC in IGE in five years,^[2] offers clinicians a first-in-class treatment that reduces PGTC seizures. These seizures increase the risk of injury and sudden unexplained death in epilepsy (SUDEP).

One third more patients experienced a reduction in seizure frequency with perampanel over 28 days versus placebo (50% responder rate 64.2% vs 39.5%, respectively; P=0.0019).^[3] Perampanel further demonstrates a reduction in PGTC seizure frequency (per 28 days) versus placebo (76.5% vs 38.4%, respectively; P<0.0001).^[4] Furthermore, 31% of patients are seizure free during the 13-week maintenance period when treated with perampanel as an adjunctive therapy, compared to 12% in the placebo group.^[3] The most common treatment-emergent adverse events were dizziness, fatigue, headache, somnolence and irritability.^[3]

"Perampanel demonstrates significant seizure reduction, improved seizure freedom rates and measurable improvements in quality of life, providing physicians with a much needed new treatment option for people living with this severe form of epilepsy. Using a Fycompa-based treatment regime will give physicians another treatment option for primary generalised tonic-clonic seizures, to ensure the best quality of life is achieved at the earliest opportunity." comments Bernhard Steinhoff, Medical Director and Executive Chief Physician, Kork Epilepsy Centre, Germany.

Generalised tonic-clonic seizures can be a dangerous type of epilepsy^[4] and are associated with high levels of stigma.^[5] The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.^[6] While the seizure generally only lasts a few minutes, the person will often feel confused or drowsy for a few minutes or up to a few days before returning to normal.^[4],[6]  Despite treatment, around 20% of people with idiopathic generalised epilepsy remain uncontrolled.^[7]

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target initiation and spread of seizures through inhibition of AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.^[8] In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime, and is the only new generation partial epilepsy treatment approved to treat adolescents (>12 years) with epilepsy from launch. Perampanel is also indicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.^[9]

"Idiopathic generalised epilepsy affects the old, the young and everyone in between. Now that perampanel has received marketing authorization people across Europe will be able to benefit from a first-in-class treatment option." commented Neil West, Vice President, Global Neurology Business Unit, Eisai EMEA.

The continued development of perampanel underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being 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. Eisai is proud to market more epilepsy products in EMEA than any other company.

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.

Since launch perampanel has helped treat 33,496 people living with epilepsy across Europe.^[10]

Further information for healthcare professionals can be found at http://www.eisai.co.uk  

About Study 332^[4]

Perampanel was administered via oral tablets, once daily, up to 8 mg/day (titration phase) and then maintained on maximum tolerated dose (the 13 week maintenance phase). The study period was divided into the pre-randomisation phase (screening and baseline periods): up to 12 weeks, the randomisation phase (treatment): 17 weeks (titration phase, 4 weeks; maintenance phase, 13 weeks) followed by an extension phase.

This Phase III, double-blind, randomised, placebo-controlled, multicentre, parallel-group trial evaluates the efficacy and safety of adjunctive perampanel for refractory tonic-clonic seizures, compared to placebo, amongst 164 patients aged 12 years and older with PGTC seizures receiving one to maximum of three anti-epileptic drugs. The study was conducted across centres in the U.S., Europe, Japan and Asia.

About Epilepsy  

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million people in Europe, and an estimated 50 million people worldwide.^[8],^[10] Epilepsy is a collection of syndromes that have many possible causes but often the cause is unknown. 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.

For the majority of idiopathic generalised epilepsy patients, a primary generalised tonic-clonic (PGTC) seizure begins with or without an aura which is followed by rigid muscle. This leads to violent muscle contraction (clonic phase) and a loss 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 few minutes or up to a few days before returning to normal.^[4],[6]  PGTC seizures can also result in risk of injury and sudden unexplained death in epilepsy (SUDEP).^[11]

About Eisai EMEA in Epilepsy  

Eisai is committed to the development and delivery of 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) Perampanel is indicated for use as a once-daily, adjunctive therapy for both primary generalised tonic-clonic seizures and for adjunctive treatment of partial onset seizures, with or without secondary generalised seizures, in patient patient with epilepsy aged 12 years or 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 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. Rheims S and Ryvlin P. Exp Opin Pharmacother. 2014;15:1417-1426. 

2. Eisai. Data on file. 2015 

3. French J et al. Adjunctive Perampanel RCT for PGTC seizures. Association of British Neurologists annual meeting 2015; Abstract #53141 

4. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures. Last Accessed May 2015 

5. Bandstra, NF, et al. Stigma of Epilepsy. Can J Neurol Sci 2008:35:436-440 

6. Epilepsy Action. Generalised seizures.  https://www.epilepsy.org.uk/info/seizures/generalised-seizures. Accessed May 2015 

7. Faught E. Rev Neurol Dis 2004;1:S34-S43 

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

9. Fycompa, Summary of Product Characteristics (updated September 2014) http://www.medicines.org.uk/emc/medicine/26951/

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

11. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502 

Date of preparation: June 2015 
Job code: Fycompa-UK0203 

SOURCE Eisai