EU approves Fycompa (Eisai) for treatment of Epilepsy

The European Commission has granted marketing authorisation approval for the use of Fycompa (perampanel) from Eisai as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with Epilepsy aged 12 years and older.The FDA issued a refusal to file letter for perampanel in July 2011, following a preliminary review of the acceptability of the original data package submitted the previous May. A resubmission from Eisai was accepted for review by the FDA in March this year.