FDA Approves Brivaracetam for Treatment of Partial-Onset Seizures in Pediatric Patients
This is the first time that the intravenous (IV) formulation of brivaracetam will be available for pediatric patients and is the only IV formulation approved for partial-onset seizures and this age group in nearly 7 years.
Brivaracetam (Briviact; UCB) has received FDA approval for the treatment of partial-onset seizures in pediatric patients ages 1 month and older, according to a press release.
The drug will be available in tablets, oral solution, and intravenous (IV) dosage forms and is approved as either monotherapy or adjunctive therapy. Furthermore, this is the first time that the IV formulation will be available for pediatric patients and is the only IV formulation approved for this indication and this age group in nearly 7 years, according to the press release.
“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,” said Raman Sankar, MD, PhD, FAAN, FAES, 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, in the press 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 one month, we have a new option that helps meet a critical need in pediatric epilepsy.
This approval fills a great need for pediatric patients with epilepsy, which can have significant impacts on development and functioning. Seizures can impair cognition with effects most severe in infancy, although few antiseizure medications are approved for the treatment of partial-onset seizures in infants.
“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 US neurology at UCB, in the press release. “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 is supported by data on long-term retention rates over 2 years, according to the press release. In an open label follow-up pediatric study, an estimated 71.4% and 64.3% of patients aged 1 month to less than 17 years with partial-onset seizures remained on treatment at 1 and 2 years, respectively.
Brivaracetam can cause psychiatric adverse events (AEs), including non-psychotic and psychotic symptoms, according to the press release. These AEs were reported in approximately 13% of adult patients taking at least 50 mg of brivaracetam per day, compared with approximately 8% of adults taking a placebo. Furthermore, 1.7% of adult patients taking brivaracetam discontinued treatment due to psychiatric AEs, compared to 1.3% of adults taking the placebo.
Brivaracetam also has an established safety and tolerability profile in adults. In clinical trials with adult patients, behavior-related AEs were not commonly reported, and the most common AEs were somnolence and sedation, dizziness, fatigue, nausea, and vomiting. The safety profile in pediatric trials was found to be similar to that of 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 supports clinical decision-making for health care providers,” said John J. Millichap, MD, FAAN, FAES, a pediatric epileptologist and adjunct associate professor of neurology at the Northwestern University Feinberg School of Medicine, in the press release. “In a patient population undergoing brain development and growth, safety and tolerability is a top concern.”
UCB Announces Briviact (brivaracetam) CV Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older. News release. UCB; August 30, 2021. Accessed August 30, 2021. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-briviact-brivaracetam-cv-now-fda-approved-pediatric