Japan-based Eisai has obtained approval for review from US Food and Drug Administration (FDA) for its antiepileptic drug Fycompa (perampanel).

The FDA accepted Eisai's supplemental new drug application (sNDA) for Fycompa, which is being developed to treat primary generalised tonic-clonic seizures (PGTC), a severe form of seizures in patients over the age of 12.

Fycompa is a non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

The sNDA application was based on a multicentre, randomised, double-blind, placebo-controlled and parallel-group trial, Study 332.

Japan-based Eisai has obtained approval for review from US Food and Drug Administration (FDA) for its antiepileptic drug Fycompa (perampanel).

The FDA accepted Eisai's supplemental new drug application (sNDA) for Fycompa, which is being developed to treat primary generalised tonic-clonic seizures (PGTC), a severe form of seizures in patients over the age of 12.

Fycompa is a non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

The sNDA application was based on a multicentre, randomised, double-blind, placebo-controlled and parallel-group trial, Study 332.