Keppra gets Europeans' vote of confidence to treat seizures

UCB also reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the approval of Keppra as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME).

UCB's variation application with the EMEA is based on a phase III, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of Keppra as adjunctive therapy in the treatment of myoclonic seizures in patients with idiopathic generalized epilepsy.

"Keppra is now the first and only newer anti-epileptic drug with both oral and intravenous formulations and we are pleased to provide European physicians and hospitals with an alternative for patients when oral administration is not feasible," said Troy Cox, president of CNS operations at UCB.

"The positive opinion with respect to Keppra's expanded indication is also encouraging news for patients living with JME and myoclonic seizures, and we look forward to receiving a final determination from the European Commission."