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EU recommends new indication for UCB drug

UCB has said that the European Medicines Agency has issued a positive opinion recommending that the European Commission grant marketing authorization for the epiliepsy drug Keppra.

The approval is for the administration of Keppra is as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy. Keppra is already licensed in the European Union for a range of epilepsy indications.

Idiopathic generalized epilepsies are a range of generalized epilepsies for which there is no obvious cause, other than an inherited predisposition.

The efficacy and tolerability of adjunctive Keppra treatment was examined in study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy. The research showed that 34.2% of those who took Keppra were free from seizures, compared with 10.7% of those in the placebo group.