The study met its primary endpoint of non-inferiority to carbamazepine, an epilepsy drug produced by Novartis under the name Tegretol. The trial compared Keppra (levetiracetam) to sustained release carbamazepine in newly diagnosed patients suffering from epilepsy with partial or generalized tonic-clonic seizures.
In the trial Keppra demonstrated that it was as effective as carbamazepine whilst providing further evidence of Keppra’s favorable tolerability.
Following these results UCB plans to file a marketing authorization application with the European Medicines Agency (EMEA) for the use of Keppra as monotherapy in patients with epilepsy and also plans to review the data with the FDA.
In the US Keppra is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. In adults, Keppra use is associated with the occurrence of central nervous system adverse events including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, as well as hematological abnormalities.
In pediatric patients four to 16 years of age, Keppra is associated with somnolence, fatigue, and behavioral abnormalities, as well as hematological abnormalities.