SUPPLEMENTARY NEW DRUG APPLICATION SUBMITTED IN JAPAN FOR FYCOMPA? AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES, PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES, AS WELL AS NEW FORMULATION
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has filed a supplementary new drug application in Japan for its in-house discovered antiepileptic drug (AED) Fycompa??(perampanel) seeking approval for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.