May 14, 2018

Briviact Approved for Pediatric Patients With Partial-Onset Seizures

The Food and Drug Administration (FDA) has approved Briviact (brivaracetam; UCB) tablets and oral solution as monotherapy and adjunctive therapy in the treatment of partial-onset seizures in patients aged ?4 years. Briviact injection, however, is still only indicated to treat partial-onset seizures in patients aged ?16 years.

The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures. Additional pharmacokinetic and open-label safety studies in patients aged 4 to <16 years were also conducted and the data showed a similar drug-response relationship between adults and pediatric patients. In addition, the safety and tolerability of Briviact was similar in patients aged 4–16 years compared with adults. Somnolence, sedation, dizziness, fatigue, nausea, and vomiting were the the most common adverse reactions seen in adult and pediatric patients.

Briviact exhibits a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain. When initiating treatment, gradual dose escalation is not required; weight-based dose adaptations have been established for pediatric patients.

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