FDA approves additional indication for Eisai's Fycompa® for epilepsy patients

June 22, 2015 - PRLog -- The U.S. Food And Drug Administration (FDA) has approved Eisai’s antiepileptic agent Fycompa® (perampanel hydrate) to be used as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. In October 2012, Fycompa was already approved as an adjunctive treatment for partial-onset seizures in epilepsy patients 12 years and older.

FDA approval for the new indication was based on a placebo-controlled clinical phase III study (Study 332) in 164 PGTC patients over the age of 12 years.  A high percentage of PGTC patients treated with Fycompa had a reduction in PGTC seizure frequency (76.5%) compared to the placebo (38.4%).  Responder rate for Fycompa was 64.2% compared to 39.5% for placebo. Additionally, 30.9% of patients treated with Fycompa did not experience PGTC seizures during the 13 week maintenance period whereas only 12.3% of placebo patients were free of PGTC seizures during that time.

The new indication for Fycompa is a crucial addition to Eisai’s extensive epilepsy product portfolio further strengthening the company’s dominance in the epilepsy market.

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