Brivaracetam Now Approved for Focal Seizure Treatment in Children as Young as 1 Month

The Food and Drug Administration (FDA) has approved an expanded indication for brivaracetam (Briviact; Atlanta, GA) as monotherapy or adjunctive therapyto treat partial-onset seizures in individuals as young as 1 month of age. Brivaracetam is available as oral solution or tables or for intravenous (IV) use, making brivaracetam available for infants when oral administration is temporarily not possible. This is the first time in nearly 7 years that an IV formulation has been approved for children this age. of. 

In an open label follow-up pediatric study, an estimated 71.4% and 64.3% of participants, age 1 month to 17 years, with partial-onset seizures (n=168), remained on treatment with brivaracetam at 1 and 2 years, respectively.

"We often see children with seizures hospitalized, so it's important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home," said Raman Sankar, MD, PhD, FAAN, FAES, distinguished professor and chief of Pediatric Neurology at the Rubin Brown Endowed Chair for the David Geffen School of Medicine at UCLA and UCLA Mattel Children's Hospital. "Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as 1 month, we have a new option that helps meet a critical need in pediatric epilepsy."

The most common adverse events that occurred in participants treated with brivaracetam (at least 5% for brivaracetam and at least 2% more frequently than placebo) were dizziness, fatigue, and nausea, somnolence and sedation, and vomiting symptoms.