Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Oral Briviact for Pediatric Epilepsy

UCB news release; 2018 May 14

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.

Citation:

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.

This Week's Must Reads

Outpatient Utilization Patterns for AD in the US, J Am Acad Dermatol; ePub 2019 Mar 15; Singh, et al

Racial Disparities in Healthcare Utilization for AD, J Invest Dermatol; ePub 2019 Mar 13; Wan, et al

Sleep Disturbances in Mothers of Children with AD, JAMA Dermatol; ePub 2019 Mar 20; Ramirez, et al

Childhood AD in the Primary Care Setting, J Am Board Fam Med; 2019 Mar-Apr; Al-Naqeeb, et al

Must Reads in Neurology

Post-Concussion Academic Support Disparities Found , J Pediatr; ePub 2019 Mar 7; Snedden, et al

Surgery/Anesthesia: Effects on Child Development, JAMA Pediatrics; ePub 2018 Nov 5; O’Leary, et al

FDA Approves Xyrem for Pediatric Narcolepsy, Pharmacy Times news release; 2018 Oct 28

Quality of Life Post-Concussion Examined, Clin Pediatr; ePub 2018 Oct 12; Howell, et al

Residential Lead Interventions’ Effect on Children, JAMA Pediatrics; ePub 2018 Aug 27; Braun, et al