Keppra® Approved By FDA For Childhood Seizures

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Main Category: Epilepsy
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 27 Jan 2012 - 9:00 PST

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In the U.S., Keppra® has been approved as adjunctive therapy for partial onset seizures in adults and children aged four years and older with epilepsy. However the UCB recently announced that the U.S. Food and Drug Administration (FDA) has now approved to lower the age restriction to include infants from the age of one month and older with epilepsy.

Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB declared:

"As a leader in epilepsy UCB has a responsibility to develop effective medicines that address unmet medical needs. Our continuing development program with Keppra® in young children demonstrates our long-term commitment to epilepsy." 



The FDA granted their approval following a double blind, randomized, multi-centre, placebo-controlled phase III study, which assessed the efficacy and tolerability of Keppra® oral solution (20-50 mg/kg/day) in 116 pediatric patients with refractory partial onset seizures. The patients were aged between one month and four years or younger. Keppra® demonstrated a substantial reduction in the frequency of partial onset seizures during the 5-day evaluation period, with 43.1% in the Keppra® group experiencing a reduction of at least 50% in seizure frequency, compared with 19.6% in the placebo group (p=0.013).

The researchers found that Keppra® was generally well tolerated by all pediatric patients, with the most commonly reported adverse events in 13.3% of patients in the Keppra group experiencing somnolence, compared with 1.8% in the placebo group, whilst 11.7% and 0% respectively suffered from irritability.

Keppra® has been granted marketing authorization in the E.U. as adjunctive treatment of partial onset seizures in infants and young children aged one month to under four years in 2009, by the European Commission.

UCB's growing epilepsy franchise has been based on Keppra® and has since been extended to include Vimpat® (lacosamide), an adjunctive therapy for the treatment of partial onset seizures in patients with epilepsy, which is marketed in the E.U. for those with epilepsy who are 17 years and older, and in the U.S. as a schedule V controlled substance for young adults with partial onset seizures with or without secondary generalization, aged 16 years and older.

Written By Petra Rattue


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