Belgium’s UCB Pharma says it has won US Food and Drug Administration priority review status for its application seeking the green light for its lead anti-epilepsy drug, Keppra (levetiracetam), as add-on therapy in children and adolescents with partial seizures.
UCB filed the paediatric application for Keppra on 20 December 2004, seeking approval specifically for the adjunctive treatment of partial seizures in children down to four years of age. The filing is based on recent pivotal trial results in 198 patients showing excellent efficacy and safety in children aged four to 16 years with refractory epilepsy. The children who took part in the study were taking one or two other anti-epileptic drugs at entry – 7% of those who took Keppra became seizure free during the 14-week 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.
Under a priority review, the FDA sets a six-month target for deciding whether to approve a New Drug Application, instead of the standard target ten-month target date. UCB notes that 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. Keppra was first marketed in 2000, and generated sales of some 417 million euros in 2004 – up 33% [[08/02/05e]]. The firm expects it could be available for children as early as the third quarter of this year.