Eisai gains FDA approval for added Fycompa indication
Japanese drug major Eisai (TYO: 4568) has received approval from the US Food and Drug Administration 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.
The FDA's decision to approve the indication expansion was based on a placebo-controlled clinical Phase III study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures.
Clinical backing
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