Atlanta-Based Company, UCB, Receives FDA Approval for BRIVIACT for Pediatric Epilepsy Patients One Month and Older
Tuesday, August 31st, 2021
UCB announced today that the U.S. 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 of age.2 This is the first time that the IV formulation of BRIVIACT will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly 7 years.
Childhood epilepsy varies in severity and prognosis and may have profound consequences on development and functioning.3,4Seizure burden can impair cognition with effects being most severe in infancy.4,5 Despite these elevated challenges, few antiseizure medications are FDA-approved for treating partial-onset seizures in this vulnerable patient population.
“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,” said Mike Davis, Head of U.S. Neurology at UCB. “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.”
BRIVIACT data in pediatric patients includes long-term retention rates over 2 years. In an open label follow-up pediatric study, an estimated 71.4% and 64.3% of patients, aged 1 month < 17 years with partial-onset seizures (n=168), remained on treatment with BRIVIACT at 1 and 2 years, respectively.1
“We often see children with seizures hospitalized, so it’s important to have a therapy like BRIVIACT IV that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” said Raman Sankar, MD, PhD, FAAN, FAES, Distinguished Professor and Chief of Pediatric Neurology at the Rubin Brown Endowed Chair for the David Geffen School of Medicine at UCLA and UCLA Mattel Children’s Hospital. “Now that BRIVIACT IV and oral formulations are an approved therapy for partial-onset seizures in children as young as one month, we have a new option that helps meet a critical need in pediatric epilepsy.”
“The pediatric safety and tolerability data for BRIVIACT and the FDA-approved indication for treating partial-onset seizures in children as young as one month supports clinical decision-making for healthcare providers.” said John J. Millichap, MD, FAAN, FAES, Pediatric Epileptologist and Adjunct Associate Professor of Neurology at Northwestern University Feinberg School of Medicine. “In a patient population undergoing brain development and growth, safety and tolerability is a top concern.”
BRIVIACT has an established safety and tolerability profile in adults. Behavior-related adverse events were not commonly reported in adult trials. The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. In the pediatric BRIVIACT trials, the safety profile for pediatric patients was found to be similar to that of adults.2
BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.2