UCB announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grant marketing authorisation for Keppra as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years.
The CHMP decision is based on the results of a phase III, double-blind, randomised, multi-centre, placebo-controlled study evaluating the efficacy and tolerability of Keppra oral solution (20-50 mg/kg/day) in 116 paediatric patients with refractory partial-onset seizures, aged from one month to under four years. Infants and children in this study were experiencing partial-onset seizures with or without secondary generalisation that were inadequately controlled despite treatment with one or two other antiepileptic drugs.
“This is the first well-controlled study providing information on the efficacy and tolerability of levetiracetam in infants and young children with inadequately controlled partial-onset seizures. The results of this study suggest that levetiracetam will be a valuable new treatment option in very young patients with partial-onset epilepsy.” said Associate Professor Jesus Eric Pina-Garza, Children’s Hospital at Vanderbilt, Nashville, Tennessee, US.
In this clinical trial Keppra was shown to significantly reduce the frequency of partial-onset seizures with 43.1% of Keppra-treated patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients (p=0.013). Keppra was generally well-tolerated in this paediatric population. The most commonly reported treatment-emergent adverse events (>5%) that occurred more frequently in the Keppra group were somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0% for placebo).
“For parents of very young children with partial-onset seizures that are poorly controlled with their current medication, the CHMP positive opinion is encouraging news. We look forward to the final determination of the European Commission and extending the availability of Keppra as adjunctive therapy to children from one month to under four years with partial-onset seizures”, said Troy Cox, President, CNS Operations, UCB.
Since its first launch in 1999, an innovative research and clinical trials programme has enabled Keppra to realise its potential as a broad spectrum antiepileptic drug. As a result, it is available for a range of seizure types and in a range of formulations (250 mg, 500 mg, 750 mg and 1 000 mg tablets, 100 mg/ml oral solution and 100 mg/ml concentrate for solution for infusion, an alternative for patients when oral administration is temporarily not feasible.