FDA Approves Keppra for Use in Childhood Epilepsy
ATLANTA, June 24, 2005 -- UCB Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company's anti- epilepsy drug Keppra (levetiracetam) as add-on therapy in the treatment of partial-onset seizures in children four years of age and older with epilepsy. The FDA approved this new pediatric indication for Keppra under a six month priority review.
"More than 25% of children with epilepsy experience treatment resistant seizures or intolerable side effects from medication," said Tracy Glauser, M.D., director of the Comprehensive Epilepsy Program, Cincinnati Children's Hospital, and principal investigator of the well-controlled study reviewed for the pediatric indication. Dr. Glauser added that, "Keppra was effective and well tolerated by the children in the study, many of whom had failed on multiple anti-epileptic drugs (AEDs) prior to trying Keppra."
"This approval provides another needed treatment option for children who suffer from epilepsy. We applaud the FDA for making this therapeutic option available," said Eric Hargis, President of the Epilepsy Foundation.
Clinical Trial Results
The approval of Keppra (levetiracetam) for children was based on findings from one multi-center, randomized, double-blind, placebo-controlled pivotal study conducted at 60 sites in North America, in 198 children 4 to 16 years of age with partial onset seizures with or without secondary generalization uncontrolled by standard AEDs.1 Study participants were taking one or two other AEDs at entry. The study consisted of an 8-week baseline period and a 4-week titration period, followed by a 10-week evaluation period.
When measuring efficacy, those taking Keppra had a significantly larger reduction (26.8%) in weekly seizure frequency over placebo, on average. Additionally, responder rates (the portion of patients achieving a 50% or greater reduction in seizures) for patients taking Keppra were 44.6% versus 19.6% for placebo (both with a p=0.0002 compared to placebo).
"We are very pleased the FDA approved Keppra for children, and look forward to making this therapy available for many of the 300,000 children in the U.S. with epilepsy," said Peter Verdru, M.D., Vice President Clinical Research and head of Neurology, Psychiatry and Clinical Development, UCB Pharma, Inc.
In pediatric patients, 4 to 16 years of age, the most common adverse events associated with Keppra in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. Keppra is associated with somnolence, fatigue, and behavioral abnormalities as well as hematological abnormalities.
In the U.S., Keppra is approved for adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Keppra is available in 250, 500 and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets. Keppra dosing must be individualized according to renal function status. Since its launch, Keppra has had more than 600,000 unique patient starts in the United States.2
In adults, Keppra (levetiracetam) 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 well-controlled adult clinical studies, the most frequently reported adverse events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.
Keppra was approved in 1999 as adjunctive therapy for adults with partial onset seizures and is the most prescribed second-generation AED used in epilepsy.3
For full prescribing information please visit the Keppra website.
- Glauser TA, Gauer LJ, Chen L and LEV N159 Pediatric Study
Multicenter, double-blind, placebo-controlled trial of adjunctive levetiracetam (Keppra) therapy (up to 60 mg/kg/day) in pediatric patients with refractory partial epilepsy.
Epilepsia 2004; 45 (supplement 7): 186
- NDCHealth Retail Pharmacy Database,
May 2000 - April 2005
- IMS NDTI Drug Use, Rolling Quarter February - April 2005
Source: UCB Pharma, Inc.
Posted: June 2005