Eisai seeks EMA approval to expand indication of Fycompa

Eisai’s antiepileptic drug Fycompa (perampanel) reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. It has been approved in over 55 countries in the world and has been used to treat over 200,000 patients globally so far.
Eisai has now submitted an application to the European Medicines Agency to expand the indication of Fycompa for pediatric patients with epilepsy, on the back of results from the phase III (Study 311) clinical study which evaluated the safety, tolerability, and relationship between efficacy and blood concentration of Fycompa when administered as an adjunctive therapy in pediatric patients with inadequately controlled partial-onset seizures or tonic-clonic seizures. Results from the Phase II (Study 232) clinical study which evaluated the pharmacokinetics, efficacy, and long-term safety of adjunctive perampanel in pediatric patients were also used.