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Publié par | eisai-europe-limited |
Publié le | 14 octobre 2013 |
Nombre de lectures | 7 |
Langue | English |
Extrait
PR Newswire
HATFIELD, England, October 15, 2013
Japanese pharmaceutical company Eisai today announces that the US Food and Drug Administration (FDA) has approved the US supply of the epilepsy drug Zonegran® (zonisamide) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will manufacture and package three different strengths of Zonegran tablet for export to the US.
The FDA supply approval for zonisamide follows the approval for the US supply of another Eisai epilepsy drug, Fycompa® (perampanel), on 11 September 2013. The manufacturing facility at Hatfield, which also includes Eisai's EMEA sales and marketing and R&D operations, is increasing in significance to the company's worldwide business as it continues becomes a global supply centre for innovative products such as zonisamide and perampanel.
Gary Hendler, President and CEO, Eisai EMEA, comments: "We are pleased to announce this new FDA approval for the US supply of Zonegran from our Hatfield manufacturing facility. This latest achievement, which follows the earlier FDA supply approval for Fycompa, is testament to the commitment our EMEA business has made to the UK."
Zonisamide was approved in the US in 2000 as adjunctive therapy for the treatment of partial seizures in adults with epilepsy.[1] It is indicated in Europe 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.[2]
The FDA approval for the manufacture and supply of zonisamide and perampanel to the US is another example of Eisai's human health care mission; the company's commitment to increasing access to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to addressing the unmet medical needs of patients and their families.
Notes to Editors:
Eisai has a long and established history of scientific investment and partnership in the UK:
Eisai in Oncology
Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
About Epilepsy
Epilepsy is one of the most common neurological conditions in the world.[3] There are an estimated six million people who live with epilepsy in Europe, and an estimated 50 million people with the condition 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:
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:
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, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
References
1. FDA zonisamide safety label 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf (Accessed September 2013)
2. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated October 2013) https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules
3. 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: October 2013
Job code: Corporate-UK2017