LONDON, June 14 /PRNewswire/ --
-- First Treatment Licensed Specifically for LGS Offers New Hope for Patients With Epilepsy
Eisai Europe Limited, (Headquarters: London, President Yutaka Tsuchiya) today announced the launch in Germany and Scandinavia of its new anti-epileptic agent Inovelon (rufinamide) indicated for adjunctive therapy in Lennox-Gastaut Syndrome (LGS).
Inovelon, a structurally novel compound, is the first treatment licensed by the European Medicines Agency (EMEA) specifically for LGS, a severe form of generalised epilepsy that develops in early childhood.
Symptoms of LGS include a variety of seizure types, with tonic-atonic seizures being the most common. Atonic seizures (rapid loss of muscle tone and consciousness), and tonic seizures (where muscles contract continuously typically producing a stiffening of the legs and arms) lead to the sudden falls seen in LGS patients known as 'drop attacks'. Absence seizures (staring spells) and myoclonic seizures (sudden muscle jerks) are also commonly observed. All children with LGS will experience varying degrees of developmental delay and behavioral problems.
In a placebo-controlled study Inovelon was found to produce a median reduction in seizure frequency of 42.5% (p=<0.0001) for drop attacks, and reduce the occurrence of total seizures by 32.7% (p=<0.0015). These differences between Inovelon and placebo were observed as early as week two during the study, suggesting a fast onset of action. Results from the extension study suggested that for subjects continuing on Inovelon, seizure reduction appeared to be maintained in the long term (up to two years).
Approximately 11,000 people across Western Europe are currently diagnosed with LGS, and it is hoped that the launch of Inovelon will contribute to improved patient and carer quality of life.
Notes to Editors
About Eisai Europe Ltd.
Established in 1989, Eisai Europe Ltd. is the European pharmaceutical subsidiary of Eisai Co. Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai focuses its efforts in two therapeutic areas; integrative neurology and integrative oncology/critical care. Eisai employs more than 9,000 people worldwide.
About Inovelon(R)
Inovelon is a structurally novel compound that acts as a broad-spectrum anticonvulsant originally discovered and developed by Novartis Pharma AG. Eisai signed an in-licensing agreement for the compound with Novartis in February 2004.
Availability
Commercial availability of Inovelon across Europe is dependant upon local regulatory requirements and pricing and reimbursement negotiations. Inovelon is currently available in the following markets;
- Austria
- Denmark
- Finland
- Germany
- Iceland
- Norway
- Sweden
and will be launched in other European countries in due course.
For further information contact:, Andrew Day, Communications Director, Eisai Europe Ltd, +44-(0)208-600-1400
