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Eisai gains positive CHMP opinion for Zonegran (Zonisamide) paediatric licence variation

Eisai Europe : 29 July, 2013  (Company News)
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Zonegran (zonisamide) as a once-daily, adjunctive treatment of partial seizures (the most common form of epilepsy) with or without secondary generalisation in children aged six and above.

Zonisamide is a novel anti-epileptic drug (AED) with multiple mechanisms of action and a structure which is chemically unrelated to any other AED. The treatment is currently indicated for adjunctive treatment of partial seizures in adults and, since July 2012, the drug can also be prescribed as monotherapy in adults with newly diagnosed partial epilepsy.

Epilepsy is a common condition in children with partial seizures being the most frequently observed seizure type. The estimated number of children and adolescents in Europe with active epilepsy is 0.9 million. Only two thirds of children and young adults with epilepsy will have seizure control once a suitable AED is found for them and many children require additional AEDs (anti-epileptic drugs) to improve seizure control. Epilepsy in children often presents major challenges such as learning and behavioural problems which can result in educational underachievement. Behavioural problems that have been associated with epilepsy include hyperactivity, aggression, autistic features, depression, and low self-esteem.

Commenting on the CHMP positive opinion, Professor Helen Cross, Honorary Consultant in Paediatric Neurology at Great Ormond Street Hospital said: "There are still a large number of children with epilepsy who do not achieve seizure control and therefore may need to trial more than one anti-epileptic drug in an attempt to reduce their seizures. In children with early onset epilepsy, improving seizure control is important for a child's health and development. Any new option for treatment is welcome for doctors specializing in epilepsy to use."

The submission to extend the use of zonisamide to include children aged six years and above was based on data from the double-blind, randomised, multicentre, placebo-controlled phase III CATZ study, which showed that zonisamide is more effective than placebo, and well tolerated in paediatric epilepsy patients (6-17 years) with partial-onset seizures treated with one or two other anti-epileptic drugs.

Specifically, results showed that significantly more patients responded (> 50 percent seizure frequency reduction) positively to treatment with zonisamide (50.0 percent) versus treatment with placebo (31.0 percent).

"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 maximise the clinical benefits of our currently licensed products," said Patrick Standen, EMEA Brand Director, Eisai Europe. "If approved in Europe as a treatment for children aged six and above, zonisamide will offer children with epilepsy a new option to help improve their seizure control."

The continued development of zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being 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 company, and is dedicated to becoming the number one epilepsy company in Europe (by sales) by 2015, as stated in its Hayabusa plan.

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