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European approval for novel Eisai epilepsy monotherapy

Published on 23/05/17 at 03:43pm
European Commission headquarters. IMAGE: Amio Cajander

Eisai and Bial have revealed that their drug Zebinix (eslicarbazepine acetate) has been awarded marketing authorisation by the European Commission as a monotherapy for the treatment of adults with newly-diagnosed, partial-onset epilepsy.

Zebinix is unlike other sodium channel blockers, and works by targeting the sodium ion channel – a possible key factor in the development of epilepsy – preventing it from returning to an active state and therefore repetitive neuronal firing. It proved its efficacy through a Phase 3 trial where it was found that 71% of those taking the drug became seizure-free for six months or more.

The therapy has already been authorised in Europe as an adjunctive treatment for adults to children as young as six with partial-onset seizures with or without secondary generalisation.

“This decision for eslicarbazepine acetate by the European Commission reinforces Eisai’s commitment to researching and developing neurological treatment options that have the potential to help people manage epilepsy more effectively," commented Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai. "This milestone means that newly-diagnosed adult patients in Europe who experience partial-onset epilepsy will now have a broader range of treatment options available.”

António Portela, CEO of Bial added: “We are pleased that adults with partial-onset epilepsy across Europe are now able to benefit from a once-daily monotherapy option that is simple to use, which may optimise their adherence. Bial has an ongoing commitment to all people living with epilepsy and we look forward to continuing to work with the epilepsy community to bring this new indication to patients.”

Matt Fellows

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