Wealth of Data for Fycompa® (perampanel) and Inovelon® (rufinamide) to be Presented at the American Epilepsy Society (AES) Annual Meeting

Sonntag, 27.11.2016 19:01 von

PR Newswire

HATFIELD, England, November 28, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS 

Data from nine abstracts for Eisai's epilepsy treatments perampanel and rufinamide will be presented at the 70th Annual Meeting of the American Epilepsy Society (AES), 2-6 December, Houston, Texas, which provide further insight into their long-term use in people with epilepsy.

Perampanel is indicated in the European Union for patients aged 12 years and older, for adjunctive treatment of partial-onset seizures (POS), with or without secondarily generalised seizures, and for adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients with idiopathic generalised epilepsy (IGE).[1]

Rufinamide is indicated in the European Union for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients with epilepsy aged four years and older.[2]

"These data provide real world insights into the activity of perampanel and rufinamide in potential patients over a wide range of ages. Through new and continued research with perampanel and rufinamide, we aim to further educate the epilepsy community about these debilitating diseases," comments Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.

The development of its epilepsy portfolio 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 neurology and to address the unmet medical needs of people with neurological conditions and their families.

Perampanel abstracts at AES (presented in the George R Brown Convention Center, Hall A3, Level 3): 


   
    Abstract Number      Abstract details     Poster # 2.189       Evaluation of perampanel as monotherapy for focal                      
    Date: Sunday 4       seizures: experience from open-label extension studies
    December
    Time: 10:00-16:00       
    Location: Hall A3,   Kwan P, Mintzer S, Laurenza A, Patten A, Cartwright K
    B3                  
   

    Poster # 2.190       Adjunctive perampanel (PER) in patients (pts) with partial
    Date: Sunday 4       seizures or primary generalized tonic-clonic seizures
    December             (PGTCS): effect of age at diagnosis         
    Time: 10:00-16:00                         
    Location: Hall A3,   Kramer L, Patten A, Laurenza A, French JA
    B3                       Poster # 2.193       Long-term efficacy and safety of adjunctive perampanel:
    Date: Sunday 4       pooled analyses of the open-label extension (OLE) studies
    December                    
    Time: 10:00-16:00   
    Location: Hall A3,   Rektor I, Krauss GL, Inoue Y, Kaneko S, Williams B, Patten
    B3                   A, Bibbiani F, Laurenza A, Wechsler RT     Poster # 2.222       A systematic review of real world perampanel treatment
    Date: Sunday 4       outcomes
    December
    Time: 10:00-16:00                            
    Location: Hall A3,   Krauss G, Tsong W, Steinhoff BJ
    B3                       Poster # 2.225       An indirect treatment comparison (ITC) of perampanel
    Date: Sunday 4       versus brivaracetam in patients with partial-onset
    December             seizures with or without secondary generalisation           
    Time: 10:00-16:00                             
    Location: Hall A3,   Tsong W, Kockelmann E, Tremblay G, Mehlig H, and Patel V
    B3
                          

    Poster # 3.238       Adjunctive perampanel in patients with drug-resistant
    Date: Monday 5       partial seizures with and without concurrent vagal nerve
    December             stimulation therapy in Phase III studies            
    Time: 08:00-14:00                             
    Location: Hall A3,
    B3                   Laurenza A, Klein P, Williams B, Patten A     Poster # 2.191       Phase II trials of adjunctive perampanel in Japanese
    Date: Sunday 4       patients with refractory partial-onset seizures, an
    December             open-label, ascending-high-dose study (study 231) and                                     
    Time: 10:00-16:00    long-term extension study (study 233)                         
    Location: Hall A3,
    B3                   Hiramatsu H, Saeki K, Ohnishi A, Kaneko S, Inoue Y     Poster # 3.232       Factors influencing the efficacy of perampanel:
    Date: Monday,        multivariate analysis of a randomized, double-blind,
    December 5           placebo-controlled Phase III study              
    Time: 08:00-14:00                             
    Location: Hall A3,
    B3                   Nishida T, Inoue Y, Kaneko S, Saeki K, Ishikawa K


Rufinamide abstracts at AES (in the George R Brown Convention Center, Hall A3, Level 3): 


   
    Abstract Number      Abstract details     Poster # 3.363       Safety and Cognitive Development Effects of Adjunctive
    Date: Monday 5       Rufinamide in Pediatric Subjects With Inadequately
    December             Controlled Lennox-Gastaut Syndrome (LGS): Final Results                                                                          
    Time: 08:00-14:00    From Study 303
                         Arzimanoglou A, Ferreira J, Satlin A, Olhaye O, Kumar D,
    Location: Hall A3,   Dhadda S, Bibbiani  F
     B3                  

 

Notes to Editors 

About Fycompa® (perampanel)  

Perampanel is a first-in-class, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist on post-synaptic neurons.[1] 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.[3] Since launch, approximately 52,000 people living with epilepsy have been treated with perampanel.[4]

About Inovelon® (rufinamide)  

Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs).[5],[6] It is believed to regulate the activity of sodium channels in the brain which carry excessive electrical charges.[5] Rufinamide was approved for adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome in Europe (under the brand name Inovelon) in 2007 in patients four years of age and older. Rufinamide is available as film-coated tablets containing 100mg, 200mg and 400mg rufinamide and as a 40mg/ml oral suspension.[2]

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.[7] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in nature and 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) is indicated for use as a once-daily, adjunctive treatment for both primary generalised tonic-clonic seizures in idiopathic generalised epilepsy and for partial onset seizures, with or without secondary generalisation, in patients aged 12 years or older
  • Inovelon® (rufinamide) is indicated 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 secondary 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 treatment 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 countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com

References 

1.    Fycompa® (perampanel) Summary of Product Characteristics (SmPC) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002434/WC500130815.pdf Accessed November 2016 

2.    Inovelon® (rufinamide) Summary of Product Characteristics (SmPC). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000660/WC500032938.pdf Accessed November 2016 

3.    Lee K et al. AMPA Receptors as Therapeutic Targets for Neurological Disorders 2016;103:203-261 

4.    Eisai. Data on File 2016. DOF PER112 

5.    Wier H et al. Rufinamide for Pediatric Patients with Lennox-Gastaut Syndrome. Pediatric Drugs 2011;13(2):97-106 

6.    Xu M et al. Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects. European Journal of Drug Metabolism and Pharmacokinetics 2016;41(5):541-548 

7.     Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf Accessed November 2016 

 


December 2016

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