Eisai's Epilepsy Drug Zonegran Approved In Spain
Eisai announced this week that Zonegran (zonisamide) has received reimbursement approval from the Spanish Directorate General of Pharmacy and Health Products, under the Spanish Ministry of Health, for treatment of epilepsy.
The directorate approved Zonegran as monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy. The drug has also been approved as adjunctive therapy in the treatment of partial epilepsy in children and adolescents six years of age and above.
Pedro Serrano-Castro of the Department of Neurology and Neurophysiology in Hospital Torrecardenas, Spain said, “The availability of zonisamide in Spain as monotherapy in adults and the widened indication for its use as adjunctive therapy in children over the age of six and beyond is welcome and will provide a new treatment option for doctors and patients.”
The pediatric approval for zonisamide was based on the Study 312 (CATZ) published in Epilepsia in July 2013. Data from the double-blind, multicenter, randomized, and placebo controlled Phase III study showed that more patients responded positively to zonisamide treatment than with placebo. Eisai’s partner Esteve has promoted Zonegran in the country since December of 2013. Once-daily zonisamide is a second generation antiepileptic drug (AED) with a unique chemical structure and multiple mechanisms of action.
Dr. Javier Sánchez, medical manager at Eisai Spain, said, “As a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to market, but also ensuring that we maximize the clinical benefits of our currently licensed products. The new extended monotherapy and adjunctive therapy indication for Zonegran provides an alternative treatment option to help improve seizure control. Zonegran is one of only six AEDs available as monotherapy, allowing doctors to tailor treatment to individual patient needs.”
Epilepsy is one of the most common neurological conditions worldwide and is estimated to affect 400,000 people in Spain alone. Successful treatment of partial onset seizures continues to be a significant challenge, with up to 30% of patients failing to achieve freedom from seizures with existing AEDs.
Source:
http://www.dddmag.com/news/2014/02/eisais-zonegran-approved-epilepsy-spain