FDA grants priority review sNDA for Fycompa in partial-onset seizures in pediatric patients.- Eisai.

The FDA has accepted its supplemental New Drug Application for Priority Review for its antiepileptic drug Fycompa (perampanel), from Eisai, CIII for monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years).

The submission also proposes a pediatric indication for adjunctive use for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy (ages 2 to less than 12 years). The sNDA application includes both the Fycompa tablet and oral suspension formulations.

In support of the extrapolation approach, the sNDA includes data from an ongoing global open-label, multicenter study (Study 311) with an extension phase that evaluated the safety, tolerability, and exposure-efficacy relationship of perampanel oral suspension when administered as an adjunctive therapy in children, ages 4 through 11, with inadequately controlled POS or PGTC seizures. The sNDA also includes data from an open-label pilot study (Study 232) with an extension phase to evaluate the pharmacokinetics, and to generate preliminary data on safety, tolerability, and efficacy of Fycompa oral suspension when given as an adjunctive therapy in pediatric subjects from 2 to less than 12 years of age with epilepsy.