New anti-seizures drug approved

Today UCB announced that the European Commission has approved the use of Keppra(R) (levetiracetam) in the European Union, as adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in children from four to sixteen years of age.
Approval was based on a pivotal paediatric clinical trial, the results of which were most recently(a) reported at the 6th European Paediatric Neurology Society Congress (14th-17th September 2005), in Sweden(1).

"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 study. "Keppra(R) was effective and well-tolerated by children in the study, many of whom had tried multiple anti-epileptic drugs prior to trying Keppra(R)."

The trial was a multicentre, double-blind, randomized, placebo-controlled study in 198 children (4-16 years old), with partial onset seizures with or without secondary generalisation uncontrolled by standard AEDs. Results show that 45% of those who received levetiracetam at a target dose of 60 mg/kg/day for 14 weeks had at least a 50% reduction in seizure frequency, and 7% became seizure free(1).

This compared with 19% (p=0.0002) and 1% respectively in placebo-treated patients. Prior to treatment with levetiracetam, the children enrolled in the study were experiencing approximately five seizures per week (median = 4.7 and 5.3 for the levetiracetam and placebo group respectively)(1).

Levetiracetam was well tolerated, and fewer children withdrew from treatment with levetiracetam because of adverse events compared to the placebo group (5% and 9% withdrawal for the levetiracetam and placebo group, respectively)(1). With the exception of somnolence (22.8% and 11.3% for the levetiracetam and placebo group, respectively), the incidence of treatment related adverse events was similar between patients in the levetiracetam and placebo groups with the most commonly reported treatment adverse events being somnolence, infection, accidental injury, vomiting and headache(1).