Eisai Co., Ltd. has announced the US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai's antiepileptic drug (AED) Fycompa (perampanel). This application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalised tonic-clonic seizures (PGTC) seizures. Furthermore, Eisai has included a study in this sNDA requested by the FDA in a Pediatric Written Request, and therefore FDA has designated this application for Priority Review, which means the review period will be six months. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of September 28, 2018.

This sNDA was based on the interim results of a Phase III clinical study (Study 311) as well as the results from a Phase II clinical study. Both studies suggested the safety and efficacy of adjunctive treatment with Fycompa was similar between pediatric patients and patients 12 years of age and older. The application aims to expand the indication for Fycompa in the United States, which currently covers monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalised seizures) in patients with epilepsy 12 years of age and older, to the age range down to 2 years of age. Based on data accumulated to date, the sNDA also seeks to expand the pediatric indication to include children 2 years of age and older for the adjunctive treatment of PGTC seizures.

Fycompa is a first-in-class AED discovered at Eisai's Tsukuba Research Laboratories. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa has been approved in countries around the world including the United States as an adjunctive treatment for partial-onset seizures (with or without secondarily generalised seizures) as well as PGTC seizures in patients with epilepsy 12 years of age and older. In the United States, Fycompa has also been approved as monotherapy for the treatment of partial-onset seizures (with or without secondarily generalised seizures). A new oral suspension formulation has also been approved and is available in the United States.

Epilepsy affects approximately 2.9 million people in the United States, 1 million people in Japan, 6 million people in Europe, and approximately 60 million people worldwide. While epilepsy affects people of all ages, incidence is particularly high among children and the elderly. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs,(1) this is a disease with significant unmet medical need.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver Fycompa throughout the world in pursuit of our mission to provide "seizure freedom" to a greater number of patients living with epilepsy. Eisai seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

Fycompa is a first-in-class AED discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa is available in tablet form to be taken once daily orally at bedtime. In addition, a new oral suspension formulation has been approved and is being marketed in the United States.

Fycompa is currently approved in more than 55 countries and territories, including the United States, Japan, in Europe and in Asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalised seizures) in patients with epilepsy 12 years of age and older. In addition, Fycompa has been approved in more than 45 countries, including the United States, Japan, in Europe and in Asia for treatment as an adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older.

Fycompa is also indicated in the United States for the treatment of partial-onset seizures (with or without secondarily generalised seizures) for monotherapy use in patients with epilepsy aged 12 and older.

Furthermore, Eisai is conducting respective global Phase III studies for the agent in pediatric patients with partial-onset seizures or PGTC seizures (Study 311) and in patients with seizures associated with Lennox-Gastaut syndrome (Study 338). Additionally, a Phase III study as monotherapy for partial-onset seizures is being conducted in Japan (Study 342).

Study 311 is a global (United States, Europe, Japan, Asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of Fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalised tonic-clonic seizures.

Following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of Fycompa orally once-daily, long term safety was assessed during an extension phase. In Japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of Fycompa orally once-daily. The adverse events (>/=10% in the perampanel arms) observed in Study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.

Study 232 was a global (United States, Europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). The study evaluated the pharmacokinetics, safety, tolerability and efficacy of Fycompa oral suspension taken at the same time as other AEDs. Administration of once-daily Fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). The most common adverse events (>/=10% in the perampanel arms) observed in Study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.