FDA OKs New Use for Eisai Antiepileptic Drug
Eisai Co., Ltd. reports that its US subsidiary Eisai Inc. has received approval from the US Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Fycompa is a antiepileptic drug discovered and developed by Eisai. 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 was approved as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older in the United States in October 2012 and was launched in January 2014.
Generalized tonic-clonic seizures can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP)1, making them one the most severe forms of epileptic seizures. Through this indication expansion, Fycompa can now be used as an adjunctive treatment for primary, in addition to, secondarily generalized tonic-clonic seizures.