FDA News

New Treatment Option for Epilepsy Patients With One of the Most Debilitating Seizure Types

(March 20, 2007)--The FDA approved UCB's leading anti-epileptic drug Keppra (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 6 years of age and older.

"Almost one in four people with epilepsy have tonic-clonic seizures, which are one of the most recognizable seizure types beginning with a sudden loss of consciousness and stiffening of the muscles, followed by rapid rhythmic jerking of the arms and legs," said Robert C. Knowlton, MD, Associate Professor of Neurology, University of Alabama at Birmingham. "Seizure freedom with minimal side effects is the ultimate goal for physicians and patients. The results of the trial supporting this new indication demonstrate the growing evidence for Keppra as an effective adjunctive therapy across partial and generalized seizure types."

"People with epilepsy want to be free to get on with their everyday lives. We are pleased that there is now an opportunity for patients with one of the most debilitating seizure types -- primary generalized tonic-clonic seizures - - to benefit from Keppra," said Troy Cox, President CNS Operations, UCB. "This latest indication for Keppra supports its broad spectrum of efficacy across partial and generalized seizures types."

Keppra was approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra has received several supplemental indications as adjunctive therapy for epilepsy, making it one of the few treatments approved to treat seizure types that together account for more than 80 percent of all seizures. These FDA indications include:

-- Partial onset seizures in patients 4 years of age and older withepilepsy
-- Myoclonic seizures in patients 12 years of age and older withJuvenile Myoclonic Epilepsy (JME)
-- Keppra(R) intravenous formulation for partial seizures as analternative for adult patients when oral administration is temporarily not feasible
-- Primary Generalized Tonic-Clonic (PGTC) seizures in patients 6 years of age and older with idiopathic generalized epilepsy

This U.S. approval closely follows the European Commission approval for Keppra in this debilitating generalized seizure type earlier this year.

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