Eisai Receives Positive Opinion for the Approval of Zonegran

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of a new drug, Zonegran, in the treatment of the most commonly observed form of epilepsy in children aged six and above.

Eisai's anti-epilepsy drug (AED) has been in use for the treatment of adults since 2012, but Professor Helen Cross, honorary consultant in Paediatric Neurology at Great Ormond Street Hospital, said that there are still a large number of children who do not receive such treatment, despite partial seizures being commonly observed in this age group, an issue which affects 30% of sufferers worldwide.

The positive opinion from CHMP was based on the results of a study that showed Zonegran had a favourable result over placebo treatment.

The double-blind, randomised, multicentre, placebo-controlled phase III CATZ study showed that 50% of six to 17 year olds treated responded well (based on a higher than 50% seizure-reduction rate) when Zonegran was used in conjunction with other AEDs, compared to just 31% who responded similarly to placebo treatment.

Of the results, Professor Cross said: "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 specialising in epilepsy to use."