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.
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, noncompetitive 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 United States in October 2012 and was launched in January 2014.
Generalized tonic-clonic seizures can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP)1, making them one the most severe forms of epileptic seizures.
Through this indication expansion, Fycompa can now be used as an adjunctive treatment for primary, in addition to, secondarily generalized tonic-clonic seizures.
Epilepsy affects approximately 2.9 million people in the United States. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs, this is a disease with significant unmet medical needs.
Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to Fycompa as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.