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

In the study, a statistically-significant reduction in PGTC seizure frequency was observed in the Fycompa group compared with placebo (Fycompa: -76.5%, placebo: -38.4%, p<0.0001). Additionally, the responder rate for Fycompa was 64.2%, which was a statistically-significant improvement over the responder rate for placebo of 39.5% (p=0.0019). Furthermore, 30.9% of patients treated with Fycompa were free of PGTC seizures (12.3% for placebo) during the 13 week maintenance period. The most common adverse events for Fycompa were dizziness, fatigue, headache, somnolence and irritability.

Fycompa is a first-in-class AED discovered and developed by Eisai. The agent is a highly selective, non-competitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa was approved as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older in the USA in October 2012 and was launched in January last year (The Pharma Letter January 2, 2014).