FDAnews
www.fdanews.com/articles/62022-ucb-s-keppra-approved-for-juvenile-myoclonic-epilepsy

UCB'S KEPPRA APPROVED FOR JUVENILE MYOCLONIC EPILEPSY

August 25, 2006

The FDA has approved the use of UCB's Keppra (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 and older with juvenile myoclonic epilepsy. Keppra is widely prescribed as an add-on therapy in the treatment of partial onset seizures in adults and children 4 and older with epilepsy. This new indication represents the first U.S. approval of the drug for the treatment of a generalized seizure type in epilepsy patients.

Juvenile myoclonic epilepsy is a common epilepsy syndrome that usually starts between the ages of 12 and 18 and accounts for about 10 percent of all cases of epilepsy. This clinical trial data supporting this new indication provides the first and only Phase III, double-blind, randomized, placebo-controlled evidence on the safety and efficacy of an antiepileptic drug as add-on therapy in juvenile myoclonic epilepsy patients.