UCB receives CHMP positive opinion on Keppra for infants and young children with partial-onset epilepsy

European marketing approval recommended for Keppra (levetiracetam) as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years

27-Jul-2009 - Belgium

UCB announced 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, U.S.

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).

https://www.bionity.com/en/news/103836/ucb-receives-chmp-positive-opinion-on-keppra-for-infants-and-young-children-with-partial-onset-epilepsy.html