FYCOMPA? NEWLY APPROVED BY U.S. FDA AS TREATMENT FOR PARTIAL-ONSET SEIZURES IN PEDIATRIC PATIENTS WITH EPILEPSY

發(fā)布時(shí)間： 2018-10-09 閱讀：1165次

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Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai's antiepileptic drug (AED) Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. Fycompa was designated for Priority Review by the FDA, and was approved approximately six months after submission. 

Discovered at Eisai's Tsukuba Research Laboratories, Fycompa is a first-in-class AED available in tablet form to be taken orally once daily. In addition, an oral suspension formulation has also been approved and is available in the United States. Fycompa 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 generalized seizures) as well as primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. Fycompa has been used to treat more than 200,000 patients worldwide in more than 55 countries across all approved indications.

【from  eisai】