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.
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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.
The trial was designed to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients over the age of 12 with uncontrolled PGTC seizures, receiving up to a maximum of three antiepileptic drugs.
According to the company, the study demonstrated that Fycompa significantly reduced PGTC seizure frequency, and improved responder rates, when compared to a placebo.
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By GlobalDataFycompa received approval in more than 40 countries, primarily in Europe and North America, to treat partial-onset seizures in patients with epilepsy over the age of 12.
Eisai said the drug was introduced in the US in January.
The company also submitted an application for European approval for additional indication of the drug, to market in the EU region.
