HATFIELD, England, January 23, 2014 /PRNewswire/ --
PRESS RELEASE FOR EUROPEAN MEDIA ONLY NOT FOR U.S. MEDIA
Zonegran also receives Swissmedic approval as adjunctive therapy for children and adolescents
Zonegran(zonisamide) has received reimbursement in Switzerland by the Federal Office of Public Health (FOPH) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. The reimbursement for zonisamide follows Swissmedic approval earlier this year. Zonisamide is also now available for the treatment of partial epilepsy in children and adolescents in Switzerland following the paediatric license extension approval by the European Commission in October 2013.
Already available in Switzerland as adjunctive therapy for the treatment of partial seizures with or without secondary generalisation in patients over the age of 18, once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[1]Monotherapy is the favoured approach in managing newly diagnosed epilepsy as most people with epilepsy may be successfully managed with the first or second monotherapy. In comparison with polytherapy, monotherapy also reduces the potential for adverse drug interactions.[2]
"Effective seizure management still remains a challenge for up to a third of people with partial onset seizure despite appropriate therapy. The reimbursement of Zonegran as monotherapy in adults and the approval as adjunctive therapy in children and adolescents offers another treatment option that can potentially help people in Switzerland achieve better seizure control," commented Dr. Gnter Krmer,Neurologist, Neurozentrum Bellevue, Zurich.
Epilepsy is one of the most common neurological conditions in the world[3]and an estimated 70,000 people live with epilepsy in Switzerland.[4]The incidence of uncontrolled partial epilepsy remains high despite many new AEDs, and between 20-40% of people with newly diagnosed epilepsy will become refractory to treatment.[5]
The efficacy and safety of zonisamide as monotherapy was demonstrated in a double-blind, randomised, multicentre study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study's primary endpoint was the proportion of seizure-free patients at six months. Zonisamidedemonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy,[6]similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg with once daily dosing. Zonisamide was considered non-inferior to carbamazepine, was well tolerated, and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.
"We are pleased to receive the new extended monotherapy and adjunctive therapy indication for Zonegran in Switzerland which reinforces Eisai's human health care mission (hhc) to provide effective treatments to patients worldwide," said Christiane Kordeuter, Epilepsy Business Unit Director, Eisai Switzerland.
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.
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Zonegran® (zonisamide) Reimbursed in Switzerland as Monotherapy Treatment for Adults With Newly Diagnosed Partial ...