The European Commission has approved the expansion of the use of UCB’s VIMPAT (lacosamide) to include monotherapy and adjunctive therapy of partial-onset (focal) seizures in children aged 4 years and older. This approval adds a new option to help manage childhood epilepsy and follows a favorable review from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
“Pediatric patients with focal seizures can still experience poor seizure control with currently available treatment options, along with a reduced quality of life,” said Alexis Arzimanoglou, MD, coordinator of the Epilepsy Program of the epilepsy unit at San Juan de Deu Barcelona Children’s University Hospital and director of the Pediatric Clinical Epileptology, Sleep disorders, and Functional Neurology department at the University Hospitals of Lyon, France, in a press release. “With the approval of lacosamide, healthcare professionals and pediatric 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.”
More than 1,056,500 patient-years of exposure, three double-blind, and three open-label extension studies have established VIMPAT’s efficacy, safety, and tolerability profile as an adjunct therapy in adults with focal seizuresThe use of VIMPAT as a monotherapy also has been demonstrated in a phase 3 double-blind study (NCT00520741).
Because the safety and drug kinetic data of VIMPAT already was established in children, the extension of approval from adults to children was conducted through extrapolation of efficacy. Once dosage and safety profiles are established, both the EMA and the U.S. Food and Drug Administration allow extrapolation of efficacy data to children from adults. However, the EMA requires following a minimum of 100 children for at least one year for safety reasons after initiation of a drug treatment. The EMA has established that focal epilepsy in children aged 4 years have similar clinical expression in adolescents and adults.
VIMPAT currently is approved in 72 countries. It was first approved in the European Union as adjunct therapy for partial-onset seizures for patients between the ages of 16-18 with epilepsy. In the U.S., VIMPAT is approved for treatment of epilepsy in patients that are aged 17 years and older.