New indication for Eisai's Fycompa in Europe

Japanese pharma major Eisai (TYO: 4523) has received approval from the European Commission for the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa (perampanel) in the treatment of pediatric patients.

This approval extends the use of Fycompa as an adjunctive therapy for partial-onset seizures (POS) (with or without secondary generalization) by expanding the approved age range from 12 years and above to four years and above, and for primary generalized tonic-clonic seizures (PGTCS) from 12 years and above to seven years and above.

The approval was based on the results of Phase III (Study 311) and Phase II (Study 232) clinical studies conducted globally to evaluate Fycompa as an adjunctive therapy in pediatric patients with POS or PGTCS. Study 311 evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa when administered as an adjunctive therapy in pediatric patients aged 4 to less than 12 years with inadequately controlled POS or PGTCS. This study showed that the safety and efficacy of the Fycompa combination therapy in pediatric epilepsy patients with poorly controlled partial seizures (ages four to less than 12 years) were similar to those in patients aged 12 years and older.