Eisai submits marketing authorization to the EU for Fycompa in new seizure indication

Japanese drug major Eisai (TYO: 4523) has submitted a marketing authorization application to the European Commission for its anti-epileptic Fycompa (perampanel). The adjunctive treatment of primary generalized tonic-clonic seizures (PGTC), perampanel is currently indicated for partial-onset seizures, with or without secondarily generalized seizures, in epileptic patients aged 12 years and older.

The filing for the new indication is based on data from a double-blind, randomized, placebo-controlled, multicenter, parallel-group trial to evaluate perampanel in refractory PGTC seizures. Results demonstrated that the drug significantly reduces PGTC seizure frequency, with the study showing a greater than 50% reduction in seizure frequency relative to baseline.

Adverse events witnessed were comparable to other perampanel studies, with the most frequent being dizziness, fatigue, headache, irritability and sleepiness.