Keppra XR™ approved in the U.S.
BRUSSELS, BELGIUM--(Marketwire - September 15, 2008) -
* As adjunctive therapy, Keppra XR offers significant partial
onset seizure reduction, proven tolerability, and once-daily
dosing
* Keppra XR is built on a trusted heritage
Brussels, BELGIUM - September 15, 2008 at 7:00 am CEST - press release, regulated information: UCB announced today that the U.S. 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 U.S. pharmacies at the end of September 2008.
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."
Building On A Trusted Heritage
"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 U.S.
Important Safety Information
Keppra XR™ extended release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy. Keppra XR™ causes somnolence, dizziness, and behavioural abnormalities. The most common adverse reactions observed with Keppra XR™ combination with other AEDs were somnolence and irritability. The adverse reactions that may be seen in patients receiving Keppra XR™ are expected to be similar to those seen in patients receiving immediate-release Keppra® tablets.
Keppra® immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioural abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities) as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra® in combination with other AEDs were somnolence, asthenia, infection and dizziness.
Keppra XR™ should be gradually withdrawn to minimize the potential of increased seizure frequency.
Dosing must be individualized according to the patient's renal function state. The dosage should be reduced in patients with impaired renal function receiving Keppra XR™. In patients with end stage renal disease on dialysis, it is recommended that immediate-release Keppra® be used instead of Keppra XRTM.
For full prescribing information, please see
www.KeppraXR.com.
In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact the U.S. UCB Medical Information at 1-866-822-0068 (press 9).
