UCB's Keppra cleared in USA as adjunct therapy

Brussels, Belgium-based biopharmaceutical company UCB says that the US Food and Drug Administration has approved the use of its product Keppra (levetiracetam), an antiepileptic agent, as an adjunctive therapy for use in the treatment of myoclonic seizures in adults and adolescents 12 year of age or older, who suffer from juvenile myoclonic epilepsy. The firm added that the indication represents the first US approval that the drug has received for the treatment of a generalized seizure type in such patients. The FDA's decision is based on data from a Phase III, double-blind, randomized, placebo-controlled assessment of the agent, which demonstrated both its safety and efficacy in an adjuvant setting.