The European Commission has ruled that UCB’s anti-epileptic Vimpat can be used in children.
The regulator approved the drug’s use as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from four years of age.
Epilepsy is a chronic neurological disorder that affects around 65 million people worldwide, with almost half of incident cases diagnosed during childhood.
According to UCB, paediatric patients can suffer from adverse events with currently available anti-epileptic medicines and, as such, there is a need for additional treatment options that may provide seizure control with a low side effect profile.
The expanded approval of Vimpat (lacosamide) is based on the principle of extrapolation of its efficacy data from adults to children, and is also supported by safety and pharmacokinetics data collected in children, the firm noted.
“Paediatric patients with focal seizures can still experience poor seizure control with currently available treatment options, along with a reduced quality of life,” said Professor Alexis Arzimanoglou, coordinator of the Epilepsy Program of the Epilepsy Unit at San Juan de Deu Barcelona Children's University Hospital and director of the Paediatric Clinical Epileptology, Sleep disorders and Functional Neurology Department at the University Hospitals of Lyon, France.
“With the approval of lacosamide, healthcare professionals and paediatric patients in the EU now have an additional treatment option for focal onset seizures, either as monotherapy or adjunctive therapy, representing a great advance to further help children aged 4 years and older suffering from epilepsy.”
Vimpat was first launched in the EU in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents (16-18 years) with epilepsy.