Zebinix (eslicarbazepine acetate), a novel anti-epilepsy treatment for adult individuals with partial epilepsy, has received reimbursement under the class A-PHT category from the Italian Medicines Agency (AIFA). Once-daily eslicarbazepine acetate is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[1]
"New, effective and well tolerated treatments with a well-balanced effectiveness/tolerability ratio are welcomed by doctors and patients," commented Prof. Roberto Michelucci. "The reimbursement of eslicarbazepine acetate in Italy too is a concrete and positive step forward as it means that we will have access to a new treatment option for the treatment of individuals with epilepsy."
In Italy, there are approximately 400,000 people with epilepsy and 25,000 new cases are diagnosed every year.[2] For the majority of people with epilepsy, seizures can be controlled with one antiepileptic drug; however, 30% of individuals with treated partial onset epilepsy still experience refractory seizures.[3]
Eslicarbazepine acetate, a new sodium channel blocker, targets sodium channels, stabilising their inactive state. Eslicarbazepine acetate was approved by the European Commission in 2009 based on data submitted which showed a reduction of seizure frequency by up to 45% in patients with partial onset seizures.[4],[5],[6] Long-term studies also show that up to 18% of patients achieved freedom from seizures with eslicarbazepine acetate as an adjunctive treatment.[7],[8] A long-term open-label extension study demonstrated a statistically significant improvement in the score for overall quality of life from baseline.[8]
Giuseppe Lo Presti, Epilepsy Business Unit Director, Eisai Italy commented; "We are delighted to announce the launch of Zebinix in Italy. Improved quality of life is one of the top priorities for doctors and patients with epilepsy alike. Eisai is committed to support research in this area by marketing and campaigning for the reimbursement of effective and well tolerated epilepsy treatments, such as Zebinix."
The launch of eslicarbazepine acetate in Italy 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. Eslicarbazepine acetate is already available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, England, Finland, France, Germany, Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Finland, Spain (co-promotion with BIAL, the developer of eslicarbazepine acetate), Wales and the U.S.
*Exclusively by BIAL
Notes to Editors
Zebinix is the EU trade name for eslicarbazepine acetate
Zebinix is under license from BIAL