FDA approves Briviact for young children with partial-onset seizures
The FDA has approved an expanded indication for Briviact CV tablets, oral solution and injection, for treating partial-onset seizures among children as young as 1 month.
“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,” Mike Davis, head of U.S. neurology at UCB, said in a press release from the drug’s developer. “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.”
The approval marks the first time an IV formulation of Briviact (brivaracetam, UCB Inc.) will be available for pediatric patients upon temporary infeasibility of oral administration. Further, it is the only FDA-approved IV formulation for treating partial-onset seizures among this patient population in approximately 7 years.
An open label follow-up pediatric study showed 71.4% and 64.3% of 168 patients aged between 1 month and 17 years with partial-onset seizures remained on brivaracetam at 1 and 2 years, respectively.
“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,” 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, said in the release. “The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home.
“Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as 1 month, we have a new option that helps meet a critical need in pediatric epilepsy,” Sankar added.
Adult trials showed behavior-related adverse events were uncommon. The most common adverse events, occurring at least 5% for brivaracetam and at least 2% more frequently than placebo, were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Pediatric trials showed a similar safety profile as that of adults.
According to the release, brivaracetam’s use has been linked to psychiatric adverse reactions, including non-psychotic and psychotic symptoms, reported among approximately 13% of adults who took at least 50 mg per day compared with 8% who took placebo. Further, 1.7% of adults discontinued treatment with brivaracetam because of psychiatric reactions compared with 1.3% taking placebo. Open-label pediatric trials showed generally similar psychiatric adverse reactions to those observed among adults.
“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 support clinical decision-making for health care providers,” John J. Millichap, MD, FAAN, FAES, pediatric epileptologist and adjunct associate professor of neurology at Northwestern University Feinberg School of Medicine, said in the release. “In a patient population undergoing brain development and growth, safety and tolerability is a top concern.”