New First-in-class Epilepsy Treatment Fycompa® (perampanel) Launches in Russia PR Newswire HATFIELD, England, June 9, 2014 HATFIELD, England, June 9, 2014 /PRNewswire/ -- Fycompa ^® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has today launched in Russia. The therapy 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. ^ 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. ^ 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 with epilepsy from launch. "New treatment options like perampanel are vital for people with partial onset epilepsy in Russia, and particularly those who live with uncontrolled seizures," commented Professor Elena Belousova, Director of Psychoneurology and Epileptology, Moscow Research Institute of Pediatrics. "Epilepsy remains a challenging condition to treat and new options such as this are always welcomed by doctors." Epilepsy is one of the most common neurological conditions in the world. ^ Around 3 out of every 1,000 people in Russia live with the condition, 82% of which have partial (focal) epilepsy. ^ Perampanel's availability in Russia is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307). ^ The three global 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. ^ ^, ^ ^, ^ 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 also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term. ^[ ^5 ^] "We are pleased to announce the launch of Fycompa in Russia as Eisai is committed to the development of innovative epilepsy therapies such as this to help people improve their seizure control," commented Olga Konopleva, Managing Director, Eisai Russia. 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 Russia 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 ^] Further information for healthcare professionals can be found at 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. ^ ^, ^ 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 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 the adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older *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 6 years and above (Zonegran is under license from the originator Dainippon Sumitomo Pharma) *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation (Zebinix is under license from BIAL) *Inovelon ^® (rufinamide) for the adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years of age and older (Rufinamide was originally developed by Novartis) About Eisai Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and 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 human health care ( hhc ). Eisai concentrates its R&D activities in three key areas: *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight management *Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc. *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, the Netherlands and the Middle East. For further information please visit our web site http://www.eisai.ru or http://www.eisai.co.uk References 1. Fycompa, Russian PIL (updated August 2013) 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 May 2014) 4. Guekht A. et al. The epidemiology of epilepsy in the Russian Federation. Epilepsy Res 2010: 92(2-3):209-18 5. Krauss GL et al. Perampanel, a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from phase III, extension study 307. Epilepsia, 2013:54(1):126-34 6. Krauss GM et al. Randomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012:78(18):1408-1415 7. French JA et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 2012:79(6):589-596 8. 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 9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (Accessed May 2014) 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: June 2014 Job code: perampanel-UK2151 Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson/Ben Speller, +44(0)7908-314-155/+44(0)845-676-1607, Cressida_Robson@eisai.net, Ben_Speller@eisai.net; Tonic Life Communications, Frances Murphy/Nicola Lilley, +44(0)207-798-9262 /+44(0)207-798-9905, email@example.com, firstname.lastname@example.org
New First-in-class Epilepsy Treatment Fycompa® (perampanel) Launches in Russia
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