21 September 2017 - Vimpat is approved for monotherapy and adjunctive therapy of partial-onset (focal) seizures in children aged 4 years and older and now provides a new treatment choice for physicians and their paediatric patients with epilepsy.

UCB today announced that the European Commission approved expanding the use of its anti-epileptic drug Vimpat (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (also known as focal-onset seizures according to ILAE terminology with or without secondary generalisation in adults, adolescents and children from 4 years of age.

The approval of Vimpat is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. The EMA has established that focal epilepsies in children older than 4 years old have a similar clinical expression to that in adolescents and adults. The FDA and EMA allow extension of indication to paediatric populations using extrapolated data provided the dose is established and the safety is demonstrated. The EMA states that, from the safety viewpoint, a minimum of 100 children treated by the study drug should be followed for at least one year.

Read UCB press release