Eisai seeks to widen Fycompa's EU label to children

Japanese drugmaker Eisai (TYO: 4523) has submitted an application to the European Medicines Agency (EMA) for its antiepileptic drug Fycompa (perampanel) seeking approval for use in pediatric patients with epilepsy.

Fycomba is already approved in Europe for adjunctive use in patients aged 12 years and older with partial-onset seizures or primarily generalized tonic-clonic seizures, and this application seeks to widen the use to children.

Discovered at Eisai's Tsukuba Research Laboratories near Tokyo, Fycompa is a highly-selective, non-competitive AMPA receptor antagonist which reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes.