FDA approves Fycompa (perampanel hydrate) to treat generalized tonic-clonic seizures- Eisai

Eisai Co., Ltd. announced that its U.S. subsidiary Eisai Inc. has received approval from the FDA 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. 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. 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, making them one the most severe forms of epileptic seizures.>

Comment: Through this indication expansion, Fycompa can now be used as an adjunctive treatment for primary, in addition to, secondarily generalized tonic-clonic seizures.

Comment: Fycompa is CHMP recommended for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy.