Zonegran (zonisamide) receives approval in Russia for the treatment of partial epilepsy in children and adolescents. Zonisamide, a novel anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AED, is indicated in Russia and Europe as monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy; and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.
Epilepsy is one of the most common neurological diseases in the world. Around three out of every 1,000 people in Russia live with epilepsy, 82% of whom have partial (focal) epilepsy. Epilepsy diagnosed in childhood has long-term implications for health and well-being and timely diagnosis and appropriate treatment are essential. Although epilepsy is common among children, only two thirds of those with the condition will achieve seizure control and many will require additional AEDs to improve seizure control.
“It is good news that we have a new treatment option available for children and adolescents with partial epilepsy in Russia. Epilepsy can affect every aspect of a child’s and their family’s life; well-tolerated and effective treatments are therefore very welcome,” commented Andrey Petrukhin, professor of the Child Neurology Department at the Russian State Medical University, Russia.
This paediatric approval in Russia is based on Study 312 (CATZ) published in Epilepsia. The double-blind, randomised, multicentre, placebo-controlled Phase 3 study showed that significantly more patients responded positively to treatment with zonisamide (50%) compared to treatment with placebo (31%), The overall incidence of treatment-emergent adverse events (TEAEs) was similar in patients receiving zonisamide compared to placebo. These data are supported by results from the long-term Phase 3 study, which demonstrate that zonisamise is well tolerated and efficacious when used as an adjunctive treatment in children aged between 6-17 years for at least one year.
“The availability of Zonegran in Russia for use in children and adolescents is in line with our on-going commitment to the therapeutic area of epilepsy and our drive to increase the benefits provided through our medicines,” commented Olga Konopleva, managing director, Eisai Russia.
Source: PR Newswire