The European Commission has approved expanding the indication of anti-epileptic agent Fycompa to include the treatment of children with epilepsy.
The European Commission (EC) has approved expanding the indication of Fycompa (perampanel) for treating children with epilepsy. Currently, around one million children and adolescents in Europe are estimated to have epilepsy, up to 20% of which have poorly controlled seizures despite medications that are available.
This treatment will now be available as an adjunctive therapy for partial-onset seizures (POS) with or without secondary generalised seizures in children from four years old and primary generalised tonic-clonic seizures (PGTC) in children from seven years old with idiopathic generalised epilepsy.
New treatment options for children
The approval was based on the results of two clinical studies, Study 311, a Phase III study, and Study 232, a Phase II study, which evaluated perampanel as an adjunctive therapy in paediatric patients. Study 311 evaluated the safety and tolerability of perampanel when administered as an adjunctive therapy in paediatric patients aged four to 12 years who live with inadequately controlled partial-onset seizures or generalised tonic-clonic seizures. Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of adjunctive perampanel in paediatric patients from two to 12 years of age.
“Eisai is very pleased to be able to provide a new treatment option for children with epilepsy. We hope it will provide better seizure control for the patients that need it, allowing them, and their families, to live the life they want to with confidence,” said Neil West, Vice President EMEA, Global Neurology Business Unit.
Professor András Fogarasi, Head of Neurology at Bethesda Children’s Hospital, Budapest and Principal Investigator on Study 311, said: “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.”