UCB announces FDA approval for Keppra in infants and children from one month of age with partial onset seizures
January 26, 2012
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra® (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures in adults and children one month of age and older with epilepsy. Keppra® was previously approved in the U.S. as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy.
The approval was based on data from a phase III, double-blind, randomized, multi-centre, placebo-controlled study evaluating the efficacy and tolerability of Keppra® oral solution (20-50 mg/kg/day) in 116 pediatric patients with refractory partial onset seizures, aged from one month to under four years. Keppra® was shown to significantly reduce the frequency of partial onset seizures with 43.1% of Keppra®-treated patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients (p=0.013). Keppra® was generally well-tolerated in this pediatric population. The most commonly reported adverse events that occurred more frequently in the treatment group were somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0% for placebo).