ATLANTA, Feb. 17 — UCB Pharma, Inc. has been granted a priority review for the supplemental new drug application (sNDA) seeking approval of its leading anti-epilepsy drug (AED) Keppra® (levetiracetam) as add-on therapy in children and adolescents with partial seizures in the USA.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. 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. The children who took part in the study were taking one or two other AEDs at entry. Seven percent of children who took Keppra® 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® treatment and 20% on placebo (p=0.0002).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.