BRIEF—Pediatric approval for UCB's Briviact

The US Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month old.

This is the first time that the IV formulation of the UCB drug has been made available for pediatric patients when oral administration is temporarily not feasible. It is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly seven years.

Childhood epilepsy varies in severity and prognosis and may have profound consequences on development and functioning. Seizure burden can impair cognition with effects being most severe in infancy. Despite this, few antiseizure medications are FDA-approved for treating partial-onset seizures in this vulnerable patient population.

Mike Davis, head of US Neurology at UCB, said: “When a child or infant suffers from epilepsy, we know that their life and the life of their caregiver is consumed by the unpredictable nature of seizures and the potentially profound consequences epilepsy can have on pediatric patients. We’ve leveraged UCB’s experience in epilepsy and commitment to innovation to expand the indication for Briviact to reduce the number of partial-onset seizures these young and vulnerable patients are experiencing and provide their caregivers with an FDA-approved treatment.”