HATFIELD, England, March 10, 2014 /PRNewswire/ --
Zonegran (zonisamide) has been approved by the Scottish Medicines Consortium (SMC) for the treatment of partial epilepsy in adolescents and children aged six years and above in Scotland.[1] This decision follows zonisamide's paediatric license extension approval by the European Commission (EC) on 3 October 2013.
Already available in Scotland as adjunctive therapy for the treatment of partial seizures, with or without secondary generalisation, in adults, zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[2]
"Uncontrolled epilepsy can affect all aspects of children and their family's lives and so new, effective and well tolerated medications are always needed," commented Professor Martin Brodie, Director of the Epilepsy Unit at the Western Infirmary in Glasgow. "My extensive experience of treating adults with zonisamide in Scotland has demonstrated its effectiveness in reducing partial onset seizures[3] and I look forward to seeing this opportunity extended to children and adolescents."
Epilepsy is one of the most common neurological diseases and affects around 54,000 people in Scotland.[4] Across the United Kingdom around 63,400 children and young people aged 18 years and under have epilepsy.[5] The successful treatment of partial onset seizures (the most common type of epilepsy) remains a challenge with more than 30% of people not able achieve seizure control with current treatments.[6]
"We are delighted that Zonegran can now be prescribed for children in Scotland," commented Patrick Standen, EMEA Brand Director, Eisai Europe Ltd. "As an emerging leader in the field of epilepsy, Eisai is committed to the development of innovative therapies such as this to help people with epilepsy."
The zonisamide paediatric approval in Scotland was based on Study 312 (CATZ) published in Epilepsia in July 2013.[7] These data from a double-blind, randomised, multicentre, placebo-controlled Phase III study, showed that that significantly more patients aged six to 17 responded positively to treatment with zonisamide (50%) versus treatment with placebo (31%),[7] Safety and tolerability assessments showed that the overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo and that there were low rates of serious TEAEs in both groups.[7]
Zonisamide was approved in Europe in 2005 as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults. In July 2012, the EC approved zonisamide as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.[2]
The continued development of zonisamide 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 epilepsy and addressing the unmet medical needs of people with epilepsy and their families. Eisai is proud to market currently more epilepsy products in EMEA than any other company.
Notes to Editors