UCB, a leading global biopharmaceutical company, announced that the US Food & Drug Administration (FDA) has approved the use of Keppra (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy (JME).
Keppra is widely prescribed as an add-on therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. This new indication represents the first US approval for Keppra for the treatment of a generalized seizure type in epilepsy patients.
Commenting on the new US approval Robert C. Knowlton, Associate Professor of Neurology, UAB Epilepsy Center, Birmingham, Alabama, USA said, 'Juvenile myoclonic epilepsy is an epilepsy syndrome that requires life-long treatment and it is paramount that therapy is both efficacious and well-tolerated in the long term. The trial supporting this new indication for Keppra presents the first class 1 evidence on the efficacy and safety of an antiepileptic drug as add-on therapy in controlling myoclonic seizures in patients with juvenile myoclonic epilepsy and provides a welcome new treatment option for US physicians and patients.'
Juvenile myoclonic epilepsy is a common epilepsy syndrome that usually starts between the ages of 12 and 18 and accounts for about 10 per cent of all cases of epilepsy1. It is characterised by myoclonic jerks that occur in 100 per cent of patients, with many also experiencing generalized tonic-clonic and absence seizures. Juvenile myoclonic epilepsy is frequently misdiagnosed and this can lead to inappropriate treatment choices.
This clinical trial supporting this new indication for Keppra provides the first and only phase III, double-blind, randomized, placebo-controlled evidence on the safety and efficacy of an antiepileptic drug as add-on therapy in patients with juvenile myoclonic epilepsy experiencing myoclonic seizures. Patients in this study included those with juvenile myoclonic epilepsy, juvenile absence epilepsy or with generalized tonic-clonic seizures on awakening. The majority were patients with juvenile myoclonic epilepsy.
Seizure frequency: The responder rate defined as = 50% reduction in myoclonic seizure days during the treatment period versus baseline was 60.4% in the Keppra group (n=54), compared with 23.7% in the placebo group (n=59) (p=0.0001)
Seizure freedom: 15.1 % of Keppra patients achieved freedom from myoclonic seizures during the treatment period compared with 3.4 % of placebo patients.