Fycompa or perampanel, an anti-epileptic agent, has now been approved by the European Commission (EC) for use in children, according to a press release by Eisai.
The drug has been approved for adjunctive treatment of partial-onset seizures with or without secondary generalised seizures in patients aged four and older. It has also been approved for use in patients aged seven and older suffering from primary generalised tonic-clonic (PGTC) seizures who have idiopathic generalised epilepsy (IGE).
This approval was based on the results of two studies, study 311 (phase III) and study 232 (phase II). Study 311 evaluated the safety and tolerability of perampanel, while study 232 looked at the pharmacokinetics, efficacy, and long-term safety.
Andras Fogarasi, Head of Neurology at Bethesda Children’s Hospital, Budapest, Hungary, and principle investigator on study 311, says, “The day-to-day impact of uncontrolled epilepsy in children can be very difficult for them to understand and manage, affecting all aspects of their lives from a very young age. Providing new treatment options to children must be done with caution, care, and diligence, and I am very happy to have taken part in this study to be able to provide this new treatment option to children, and their families, who are in desperate need of support with their condition.”