UCB's Keppra Approved to Treat Juvenile Epilespy
Posted on: Thursday, 24 August 2006, 15:00 CDT
UCB's Keppra has been approved by the FDA as an adjunctive therapy for the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Keppra (levetiracetam) 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 of Keppra as a treatment for a generalized seizure type in epilepsy patients.
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.
In terms of seizure frequency, results from the study showed the responder rate, as greater than or equal to 50% reduction in myoclonic seizure days during the treatment period versus baseline, to be 60.4% in the Keppra group, compared with 23.7% in the placebo group.
In addition, 15.1 % of Keppra patients achieved freedom from myoclonic seizures during the treatment period, compared with 3.4 % of placebo patients.
Source: Datamonitor
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