FDA Grants Priority Review to Keppra for Use in Childhood Epilepsy

UCB Pharma has been granted a priority review for the supplemental new drug application (sNDA) seeking approval of its leading antiepilepsy drug (AED) Keppra as add-on therapy in children and adolescents with partial seizures in the U.S.

The application is based on recent pivotal trial results in 198 patients showing excellent efficacy and safety in children aged 4 to 16 years with refractory epilepsy. The children who took part in the study were taking one or two other AEDs at entry. Seven percent of children who took Keppra became seizure-free during the 14-week ,double-blind, placebo-controlled treatment period, compared with 1 percent of those taking placebo. Responder rates -- a 50 percent or greater reduction in seizures -- were 45 percent on Keppra treatment and 20 percent on placebo.

In the U.S., Keppra is approved for adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Keppra is available in 250-, 500- and 750-mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets.