FDA approves UCB's Keppra for treatment of partial onset seizures in infants

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.

"As a leader in epilepsy, UCB has a responsibility to develop effective medicines that address unmet medical needs," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "Our continuing development program with Keppra^® in young children demonstrates our long-term commitment to epilepsy."

The approval was based on data from a Phase III, double-blind, randomized, multi-center, 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. 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).

In 2009, the European Commission granted marketing authorisation for Keppra^® in the European Union as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years. Keppra^® has provided the foundation for UCB's growing epilepsy franchise which has been extended to include Vimpat^® (lacosamide) which is marketed in the European Union as adjunctive therapy for the treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older and in the U.S. as adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy, aged 17 years and older. In the U.S. Vimpat^® is a Schedule V controlled substance.