UCB announced that the FDA has approved Keppra (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures in children one month of age and older with epilepsy. This approval was based on data from a Phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy and tolerability of Keppra oral solution 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 tablets and oral solution are already indicated for use in children and adults ≥4 years old for partial onset seizures. The oral formulations of Keppra are also indicated as an adjunct in myoclonic seizures in patients ≥12 years old with juvenile myoclonic epilepsy and as an adjunct in primary generalized tonic-clonic seizures in patients ≥6 years old with idiopathic generalized epilepsy.
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