UCB'S KEPPRA APPROVED FOR NEW EPILEPSY INDICATION

The FDA has approved UCB's antiepileptic drug Keppra as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 and older with idiopathic generalized epilepsy (IGE), the company announced.

In epidemiological studies, generalized seizures account for roughly 40 percent of cases, with the incidence of generalized tonic-clonic seizures estimated at 23 percent. The new indication, which is the fourth for Keppra (levetiracetam) tablets and oral solution in the U.S., confirms the broad-spectrum efficacy of Keppra, UCB said. This approval follows the European approval of Keppra for the same indication earlier this year.

In a multicenter, randomized, double-blind, placebo-controlled clinical trial of Keppra as add-on treatment in 164 patients with refractory IGE, nearly a quarter of patients achieved complete seizure freedom from all seizure types over the 20-week evaluation period compared with only 8.3 percent of those who received a placebo in addition to their usual treatment.

Keppra is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults and children 4 and older with epilepsy and as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 and older with juvenile myoclonic epilepsy, in addition to the new indication.