UCB Receives Positive Opinion On Keppra From CHMP

UCB has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), for Keppra.

Reportedly, the positive opinion recommends the granting of a marketing authorization for Keppra by the European Commission. It is to be used as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years.

CHMP’s decision is based on the results of a phase III, double-blind, randomised, multi-centre, placebo-controlled study. The trial was to evaluate the efficacy and tolerability of Keppra oral solution (20-50 mg/kg/day) in 116 paediatric patients with refractory partial-onset seizures, aged one month to under four years.

Troy Cox, president of CNS Operations at UCB, said: 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.