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Levetiracetam Granted Priority Review Status in Childhood Epilepsy
Under a priority review, the Food and Drug Administration (FDA) sets a six month target for deciding whether to approve a new drug application, instead of the standard target of 10 months after the date the application is filed. A priority designation is intended for products that address unmet medical needs and, if approved, would be a significant improvement on products already on the market.
UCB Pharma, Inc. submitted the pediatric sNDA for Keppra on 20 December 2004, requesting approval of Keppra for the adjunctive treatment of partial seizures in children down to four years of age. Keppra was first marketed in the year 2000 and is now the most prescribed second generation AED for adults with partial onset seizures in the USA.(1) The introduction of Keppra for children, as early as Q3 2005 in the US and EU, will give even more patients the opportunity to receive this innovative medicine.
The application is based on recent pivotal trial results in 198 patients showing excellent efficacy and safety in children aged 4-16 years with refractory epilepsy.(2) The children who took part in the study were taking one or two other AEDs at entry.(2) Seven percent of children who took Keppra(R) became seizure free during the 14 week double-blind, placebo controlled treatment period, compared with 1% of those taking placebo. Responder rates - a 50% or greater reduction in seizures - were 45% on Keppra(R) treatment and 20% on placebo (p=0.0002).(2)
Dr. Tracy Glauser, Director Comprehensive Epilepsy Program, Cincinnati Children's Hospital, and principal investigator of the study stressed the importance of early, aggressive treatment of childhood seizures to lesson the risk of injury to the child, maximize school performance, and thereby improve their quality of life.
"Keppra was effective and well tolerated by the children in our study, many of whom had been on eight or nine different drugs before trying Keppra," he said.
In the U.S. Keppra is approved for adjunctive therapy in the treatment of partial onset seizures in adults 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. Taken with or without food, the effective recommended starting dose of Keppra is 1,000 mg/day given twice daily (500 mg bid). Since its launch, Keppra has had more than 500,000 unique patient starts in the United States.(3)
Keppra 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. Keppra dosing must be individualized according to renal function status. In well-controlled 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.
The recent identification of SV2A as a binding site for levetiracetam confirms that Keppra possesses a mechanism of action that is truly distinct from that of all other AEDs.
* For full U.S. prescribing information consult http://www.keppra.com/. Outside of the U.S., please consult local prescribing information.
(1) Available from: IMS Health, National Disease and Therapeutic Index TM. Accessed Oct 2004.; Based on an intent-to-treat (ITT) analysis; when generalized seizures were specified, the data were excluded from this analysis.
(2) Glauser TA, Gauer LJ, Chen L and LEV N159 Pediatric Study Group. Multicenter, double-blind, placebo-controlled trial of adjunctive levetiracetam (Keppra(R)) therapy (up to 60 mg/kg/day) in pediatric patients with refractory partial epilepsy. Epilepsia 2004; 45 (supplement 7): 186 (B.03)
(3) Available from: Verispan Retail Pharmacy Database. Accessed May 2004.
Source: UCB Pharma, Inc.