UCB has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application for the company's newest anti-epileptic drug Briviact (brivaracetam) CV oral formulations, indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients aged ≥4 years. This approval provides clinicians with the convenient option to prescribe Briviact to their pediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children. UCB is headquartered in Brussels, Belgium, and Atlanta, GA.
As the safety of Briviact injection has not been established in pediatric patients, the injection is indicated for the treatment of partial-onset seizures only in patients aged ≥16 years.
Dosage/administration: Tablets are available in doses of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg; oral solution: 10 mg/mL. For pediatric patients (aged 4 to <16 years), the recommended dosage is based on body weight and is administered orally twice daily.
Adverse reactions: Most common adverse reactions in pediatric patients are similar to those seen in adult patients, such as somnolence/sedation, dizziness, fatigue, and nausea/vomiting.
UCB announces BRIVIACT (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in pediatric epilepsy patients. [news release]. Brussels, Belgium and Atlanta, GA: UCB. May 14, 2018. https://www.prnewswire.com/news-releases/ucb-announces-briviact-brivaracetam-now-approved-by-fda-to-treat-partial-onset-focal-seizures-in-pediatric-epilepsy-patients-682528591.html. Accessed June 25, 2018.