Keppra XR approved in the U.S. for partial onset seizures

Sep 15 2008

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."

"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.