After receiving original approval in 2016, brivaracetam is now available as both monotherapy or adjunctive therapy to treat partial-onset seizures in pediatrics 1 month of age and older.
The FDA has approved an expanded indication for brivaracetam (Briviact; UCB Pharma) CV tablets and oral solution, a treatment for pediatric patients with partial-onset seizures. The indication also includes an intravenously (IV) administered formulation, for when oral administration is temporarily not feasible. It is the first IV agent for this indication in nearly 7 years.1
Brivaracetam, a third-generation antiepileptic racetam derivative and a 4-n-propyl analogue of levetiracetam (Keppra; UCB Pharma), is now approved as both monotherapy or adjunctive therapy and is administered in tablets, oral solution, and IV dosage forms.
"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, Neurology, UCB, said in a statement.1 "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 basis for the approval stems from long-term data which showed high retention rates of the therapy across a 2-year stretch. In an open-label follow-up study that included 168 pediatrics with partial-onset seizures, 71.4% and 64.3% of patients, remained on treatment at 1 and 2 years, respectively.1
UCB’s agent received approval from the FDA for brivaracetam in 2016 as an add-on therapy for adult patients and was then approved as a monotherapy for adults in September 2017. It later received expanded indication as an adjunctive therapy to treat patients aged 4 years and older with partial-onset seizures in 2018.
"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," Raman Sankar, MD, PhD, FAAN, FAES, chief of pediatric neurology and Rubin Brown Endowed Chair, David Geffen School of Medicine, UCLA, said in a statement.1 "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."
Brivaracetam has demonstrated a well-tolerated safety profile that has been similar in both pediatric and adult studies. The most commonly observed adverse events reported in adults were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
"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," John J. Millichap, MD, FAAN, FAES, pediatric epileptologist and adjunct associate professor of neurology, Northwestern University Feinberg School of Medicine, said in a statement.1 "In a patient population undergoing brain development and growth, safety and tolerability is a top concern.”
A phase 2a, open-label, single-arm, fixed 3-step dose-escalation trial (NCT00422422) published in 2019 provided preliminary information that short-term adjunctive brivaracetam treatment is well-tolerated in children aged 1 month to 16 years old with epilepsy.2 In that study, 90% of the 100 patients enrolled completed the trial, with treatment-emergent AEs reported by 32.3 (32 of 99) patients. The at least 50% responder rates were 21.3% (all patients, n = 80) and 26.4% (patients with focal seizures, aged 4 to <16 years, n = 22).