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Feb 18

Eisai’s Epilepsy Treatment Zonegran® (Zonisamide) Approved for Use in Children and Adolescents in France

On the February 9, the Transparency Commission of the French National Authority for Health (HAS) published its advice on Zonegran® (zonisamide) in its new indication for the treatment of partial seizures in adolescents and children from 6 years of age.[1] Zonisamide, a novel anti-epileptic drug (AED) with a multimodal mechanism of action and a chemical structure unrelated to any other AED, was already indicated in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults. Now, adolescents and children from 6 years of age will be able to benefit from this treatment as an adjunctive therapy.

Epilepsy is a serious neurological disorder in childhood and has long-term implications for health and well-being.[2] Around 450,000 people in France live with the condition, with over 100 new cases diagnosed each day.[3] Although epilepsy is common in paediatrics, seizure control is only achieved in two thirds of patients and many will require additional AEDs to decrease the seizure frequency.[4]

“New therapeutic options for young people with epilepsy are needed, so I am delighted to see that zonisamide can now be prescribed in France for people aged six and above,” said Dr Stéphane Auvin, Epileptologist & Child Neurology at Pediatric Neurology, Robert Debré Children Hospital, Paris. “Epilepsy has an impact on all aspects of children and their family’s lives. New, effective and well tolerated treatments that can be used in children that achieve a balance between stopping seizures and keeping side effects to a minimum are welcomed by doctors, patients and parents.”

The Zonegran license extension in paediatrics was granted by the European Commission in October 2013. This paediatric approval was based on study 312 (CATZ) published in Epilepsia in July 2013.[5] The double-blind, randomised, multicentre, placebo-controlled Phase III study showed that significantly more patients responded positively to treatment with zonisamide (50%) compared to treatment with placebo (31%), p=0.0044.[4] The overall incidence of treatment-emergent adverse events (TEAEs) was similar in patients receiving zonisamide compared to placebo.[4]

“As a research-based pharmaceutical company and a leader in epilepsy, Eisai is not only committed to bringing innovative new therapies to market, but also ensuring that we maximise the clinical benefits of our currently licensed products,” commented France Roizen, Epilepsy Brand Lead, Eisai France. “We hope that the availability of Zonegran for use in children and adolescents in France will help many young people with epilepsy gain clinical benefit from the medicine.”

The continued development of zonisamide underscores Eisai’s human health care (hhc) mission, the pharmaceutical company’s commitment to innovative solutions in 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 patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other pharmaceutical company.

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