Eisai’s Zonegran receives CHMP recommendation for paediatric use

Eisai has announced that its antiepileptic agent Zonegran has had its paediatric licence extension application endorsed by Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has recommended adjunctive Zonegran for approval in the treatment of partial seizures among paediatric patients aged six years and above, compared to the current approved age range of 18 years and above.

First made available in Europe in 2005, the product has been shown in phase III testing to be safe and effective among younger patients.

It was originally created by Dainippon Pharmaceutical Co and received an additional approval as a monotherapy for partial-onset seizures in adults with newly diagnosed epilepsy last year.

The company said: "By offering multiple treatment options as part of its abundant product portfolio in the epilepsy area, Eisai seeks to make further contributions to address the diversified needs of … patients with epilepsy and their families."

Last month, Eisai announced plans for an additional packaging facility at its UK production site in Hatfield to support the launch of a number of new products.