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Published on 29 July 2011

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EMA accepts epilepsy drug Zonegran for review

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The European Medicines Agency (EMA) has accepted for review Eisai’s application to extend the use of Zonegran (zonisamide) as monotherapy for newly diagnosed epilepsy patients with partial seizures, with and without second generalisation.

Zonisamide is a second-generation anti-epileptic drug with multiple mechanisms of action, with a chemical structure unrelated to other anti-epileptic drugs, and with pharmacokinetic properties allowing a once daily regimen.

It is approved in the European Union as an adjunctive therapy in the treatment of partial seizures (with or without secondary generalisation) in adults with epilepsy.

Epilepsy is one of the most common neurological conditions in the world, affecting around six million people in Europe alone.

The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre study, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine (CBZ) (Tegretol® retard) as monotherapy in 583 adults with newly diagnosed partial epilepsy.

The study’s primary endpoint was the proportion of seizure-free patients at 6 months (per protocol population). The results of the study showed that zonisamide was effective and well tolerated in newly diagnosed epilepsy patients when used as monotherapy.

“As a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to the market, but also ensuring that we maximise the clinical benefits of our currently licensed products,” said Dr Bettina Bauer, Head of the EU Epilepsy Business Unit at Eisai Europe.

“If approved as monotherapy, zonisamide will offer newly diagnosed epilepsy patients a new option to help improve their seizure control.”

EMA



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