The anti-epileptic drug (AED) lacosamide (VIMPAT) has received a positive opinion on a licence extension, meaning it can be used as monotherapy and adjunctive therapy in the treatment of focal-onset seizures (FOS) in children from 4-16 years of age.
The licence extension was granted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The positive opinion is based on the principle of extrapolation of lacosamide efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children.
The European Commission’s (EC) approval decision is expected in the third quarter of 2017, which would further broaden the clinical application of lacosamide, and make a new treatment option available to aid the management of childhood epilepsy.
Jeff Wren, Head of UCB’s Neurology Patient Value Unit, said: “The management of paediatric epilepsy is challenging and poor seizure control can be a great burden of stress for children and their families.
“UCB is proud to play a part in improving the lives of children with epilepsy and we look forward to making this therapy available to this patient population in the EU, pending EC approval.”
The established efficacy, safety and tolerability of adjunctive lacosamide therapy in adults with focal seizures was previously demonstrated by three primary double-blind, placebo-controlled studies and three open-label extension studies.
The efficacy, safety and tolerability profile of first-line lacosamide monotherapy has been demonstrated in a phase 3, double-blind, active comparator trial and the related open-label extension study. Lacosamide has over 1,056,500 patient-years of exposure.
Professor Helen Cross, Honorary Consultant in Paediatric Neurology at UCL Institute of Child Health, said: “Non-adherence to AEDs is a common problem for children with epilepsy, in particular those with newly diagnosed epilepsy. Non-adherence is a potentially remediable cause of poor seizure control; continued seizures can be devastating and lead to long-term physical, behavioural and psychological consequences for children.
“There are currently few AEDs which are licensed for the treatment of younger children with focal onset seizures, especially as monotherapy. As such, the availability of lacosamide would provide an additional treatment option to support healthcare professionals in the management of childhood epilepsy.”