European Commission grants marketing authorization to Eisai's Fycompa

The European Commission has granted marketing authorization approval for Fycompa (perampanel) from Eisai (TYO: 4523) as a once-daily adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in adults and adolescents with idiopathic generalized epilepsy.

Perampanel is the first new treatment for PGTC in this indication in five years. One third more patients experienced a reduction in seizure frequency with perempanel over 28 days versus placebo. Perampanel further demonstrates a reduction in PGTC seizure frequency per 28 days versus placebo (76.5% versus 38.4% respectively), and 31% of patients are seizure-free during the 13-week maintenance period when treated with perampanel as an adjuctive therapy, compared to 12% in the placebo group.

The most common treatment-emergent adverse events were dizziness, fatigue, headache, somnolence and irritability.