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, US.
In this clinical trial Keppra was shown to significantly reduce the frequency of partial-onset seizures with 43.1 per cent of Keppra-treated patients experiencing at least a 50 per cent reduction in seizure frequency during the evaluation period (five days) compared with 19.6 per cent 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.
In Europe Keppra is approved as: Monotherapy in the treatment of partial-onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy; Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults and children from four years of age with epilepsy; Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; Adjunctive therapy for the treatment of primary generalised tonic clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy
Keppra provided the foundation for UCB's growing epilepsy franchise which has now been extended to include Vimpat (lacosamide) which is marketed in Europe as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older and in the US as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy, aged 17 years and older. In the US Vimpat is a Schedule V controlled substance. Also, in the US in 2008, Keppra XR was approved as an add-on to other antiepileptic treatments for people with partial-onset seizures aged 16 years of age and over.