UCB announced that the US Food and Drug Administration (FDA) has approved Keppra XR (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial onset seizures who are 16 years of age and older.
Keppra XR is expected to be available in US pharmacies at the end of September 2008, an UCB press release said.
The goal of therapy with antiepileptic drugs (AEDs) is freedom from seizures and minimal side effects. While many people with epilepsy are successfully treated with one or more of the currently available AEDs, a significant percentage still live with uncontrolled seizures or intolerable side effects.
"With solid clinical trial data supporting Keppra XR efficacy and tolerability, this once-daily antiepileptic drug can play an important role in treating people with epilepsy," said lead investigator Dr. Jukka Peltola, Department of Neurology, Tampere University Hospital, Finland. "We found in the clinical trial that Keppra XR provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."
"This is one of many milestones at UCB to develop new treatment options for people with epilepsy," said Troy Cox, senior vice president UCB & president CNS Operations. "Keppra XR provides a way to simplify treatment and offers another chance to achieve seizure control, which is an important goal for patients living with epilepsy."
The immediate release tablet form of Keppra (levetiracetam) was first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since then, Keppra has become a leading antiepileptic drug in the US.
UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007.