The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
The most common adverse events associated with lacosamide are dizziness, headache, nausea, and diplopia. In addition, antiepileptic drugs such as lacosamide are associated with an increased risk of suicidal behavior or ideation, and patients should be monitored for new or worsening depression.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD , professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website .
