UCB has announced that its epilepsy drug Vimpat has been approved in Europe for use in the treatment of children.
The European Commission has ratified an expansion to the label of the antiepileptic drug, allowing it to be used as a monotherapy and adjunctive treatment for partial-onset seizures with or without secondary generalisation in adults, adolescents and children from four years of age.
“UCB's epilepsy drug Vimpat has been approved for paediatric use in Europe.“
This decision was based on an extrapolation of its efficacy data from adults to children, given that focal epilepsies in children have a similar clinical expression to that in adolescents and adults, and is supported by safety and pharmacokinetics data collected in children.
In order to ensure its safety, the European Medicines Agency has also deemed that a minimum of 100 children treated by the study drug should be followed for at least one year.
Jeff Wren, executive vice-president and head of UCB's neurology patient value unit, said: "One of our key commitments at UCB is to improve the lives of people with epilepsy, and we are proud to be providing a proven treatment option for this highly impacted patient population."
Vimpat has been approved in 72 countries to date and has accrued more than 1,056,500 patient-years of exposure.
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