Eisai has had its application for its epilepsy drug Zonegran to be used among paediatric patients accepted for review in Europe.
The European Medicines Agency has ratified the licence extension application submitted by the UK-based Eisai Europe, which requests the use of adjunctive Zonegran in the treatment of partial seizures to be expanded to include patients aged six years and above.
“Eisai's licence extension application for its drug Zonegran to be used as an antiepileptic agent for paediatric patients has been accepted for review by the European Medicines Agency.“
Phase III clinical trial results have demonstrated the safety and efficacy of the treatment among this patient group, with data collected from more than 200 subjects.
This comes after Zonegran received a new European approval as a monotherapy for partial seizures in adults with newly-diagnosed epilepsy last week.
A statement from the company said: "Eisai seeks to make further contributions to address the diversified needs of - and increase the benefits provided to - epilepsy patients and their families."
Zonegran was also recently approved for use in Russia, making it the first Eisai product to be ratified for sale in the country.