13 February 2019 - Eisai announced today that it has submitted an application to the EMA for its in-house discovered anti-epileptic drug 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.

Read Eisai press release