US regulators have expanded the scope of Eisai’s first-in-class epilepsy drug Fycompa to include the treatment of patients with a severe form of epileptic seizures.
Fycompa (perampanel) can now be used as an adjunctive therapy for primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
PGTC seizures - one of the most common types of generalised seizures, representing about 60% of generalised epilepsy cases and 20% of all cases - can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy.
Expanded approval was based on Phase III data (Study 332) showing a statistically significant reduction in PGTC seizure frequency in patients given Fycompa compared with those taking a placebo: -76.5% versus -38.4%, respectively.
The drug, a highly selective, noncompetitive AMPA receptor antagonist, was first approved in the US in 2012 as an adjunctive treatment for partial-onset seizures (with or without secondarily generalised seizures) in patients aged 12 years and above.