Tokyo : Eisai Co., Ltd. announced today that it has submitted an application to the European Medicines Agency (EMA) for its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) seeking approval for use in pediatric patients with epilepsy.

This application aims to expand the indication for Fycompa, which is already approved for adjunctive use in patients aged 12 years and older with partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures, to cover pediatric patients as well.

This application was based on the results of Phase III (Study 311) and Phase II (Study 232) clinical studies conducted globally to evaluate Fycompa as adjunctive therapy in pediatric patients. Study 311 evaluated the safety, tolerability, as well as relationship between efficacy and blood concentration of Fycompa when administered as an adjunctive therapy in pediatric patients (age 4 to less than 12 years) with inadequately controlled partial-onset seizures or tonic-clonic seizures. Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of adjunctive perampanel in pediatric patients (from 2 to less than 12 years of age). Detailed results of both studies will be presented at upcoming academic conferences, respectively.

Discovered at Eisai’s Tsukuba Research Laboratories, Fycompa is a first-in-class AED that is a highly selective, noncompetitive AMPA receptor antagonist which reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Available in tablet form to be taken orally once daily, Fycompa has been approved in over 55 countries in the world and has been used to treat more than 200,000 patients worldwide to date. Regarding the indication covering pediatric patients, Fycompa was approved in the United States in September 2018, and an application was submitted in Japan in January 2019.

It is estimated that there are approximately 6 million patients with epilepsy in Europe, and although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and in continued pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.