The Food and Drug Administration has expanded the approval of Briviact® (brivaracetam) tablets, oral solution, and injection for intravenous (IV) use to include treatment of partial-onset seizures in patients 1 month of age and older.
Previously, the oral formulations for Briviact were only approved for patients 4 years of age and older, and the IV formulation was only approved in patients 16 years of age and older. The IV formulation is available for patients when oral administration is temporarily not feasible.
The use of brivaracetam in these age groups is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to less than 16 years of age. According to the Company, findings from an open label follow-up pediatric study showed an estimated 71.4% and 64.3% of patients, aged 1 month to less than 17 years (N=168), remained on treatment with brivaracetam at 1 and 2 years, respectively.
The safety profile of Briviact in pediatric patients was generally similar to that observed in adults. The most common adverse reactions included somnolence, sedation, dizziness, fatigue, nausea, and vomiting. Decreased appetite and psychiatric adverse reactions were also reported in open-label pediatric trials.
Briviact, a CV controlled substance, is supplied as 10mg, 25mg, 50mg, 75mg, and 100mg strength tablets, as a 10mg/mL strength oral solution, and as a 50mg/5mL strength solution for IV use. In pediatric patients weighing less than 50kg, the recommended dosing regimen is dependent upon body weight. The tablet formulation should not be chewed or crushed.
- UCB announces Briviact® (brivaracetam) CV now FDA-approved to treat partial-onset seizures in pediatric patients one month of age and older. News release. UCB, Inc. Accessed August 30, 2021. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-briviact-brivaracetam-cv-now-fda-approved-pediatric.
- Briviact® [package insert]. Smyrna, GA: Briviact, Inc.; 2021.