BRUSSELS, Aug. 23 (UPI) -- UCB said Wednesday the U.S. Food and Drug Administration has OK'd Keppra as adjunct therapy for juvenile myoclonic epilepsy (JME).
UCB said its anti-seizure treatment has been approved to treat myoclonic seizures in people 12 years of age and older who have JME.
The expanded indication marks Keppra's first U.S. approval for the treatment of a generalized seizure type in epilepsy patients, the company said.
Keppra is already approved as an add-on therapy for partial onset seizures in epilectic adults and children four years of age and older.
"The trial supporting this new indication for Keppra presents the first class 1 evidence on the efficacy and safety of an antiepileptic drug as add-on therapy in controlling myoclonic seizures in patients with juvenile myoclonic epilepsy and provides a welcome new treatment option for U.S. physicians and patients," said Robert Knowlton, associate professor of neurology at the UAB Epilepsy Center in Birmingham, Alabama, in a statement issued by the company.
Juvenile myoclonic epilepsy is a common syndrome seen in about ten perecent of all epilepsy cases, usually starting between the ages of 12 and 18, UCB said.