Davis offered comments on the recent approval of brivaracetam (Birviact; UCB) as a treatment for pediatric patients with partial-onset seizures and its potential for these patients.
On Monday, the FDA approved the expansion of the indication of brivaracetam (Birviact; UCB Pharma), giving the green light for the CV tablets, oral solution, and intravenous (IV) formulation as a treatment for pediatric patients with partial-onset seizures. The IV formulation is indicated for instances when oral administration is temporarily not feasible.
The basis for this new pediatric 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
Previously, a phase 2a, open-label, single-arm, fixed 3-step dose-escalation trial (NCT00422422) offered data suggesting that short-term adjunctive treatment with brivaracetam is well-tolerated among pediatric patients aged 1 month to 16 years with epilepsy. In that study, 90% of the 100 patients enrolled completed the trial, with treatment-emergent AEs reported by 32.3 (32 of 99) patients. Response rates of at least 50% were recorded by 21.3% (n = 80) and 26.4% of all patients and patients with focal seizures (aged 4 to <16 years; n = 22), respectively.2
Additional data from the 2020 American Epilepsy Society (AES) Annual Meeting, conducted by Pavel Klein, MD, director, Mid-Atlantic Epilepsy and Sleep Center and colleagues found that patients with a lesser history of AEDs were less likely to discontinue brivaracetam due to lack of efficacy or treatment-emergent adverse events, and that long-term efficacy was highest in patients with 1-2 lifetime antiepileptic drugs (AEDs) and decreased by the number of lifetime AEDs. While patients exposed to 7 or more AEDs had a lesser response to brivaracetam, they were still seen to benefit from long-term brivaracetam treatment.3
The third-generation antiepileptic racetam derivative and a 4-n-propyl analogue of levetiracetam (Keppra; UCB Pharma) is now approved as both monotherapy and adjunctive therapy for this patient population. The UCB therapy originally received agency approval in 2016 as an add-on therapy for adult patients, then getting its monotherapy indication for adults in September 2017. Its label was expanded again in 2018 to include an indication as an adjunctive therapy to treat patients aged 4 years and older with partial-onset seizures.
To find out more about this new indication, NeurologyLive inquired with Mike Davis, head, Neurology, UCB, to hear more about how this approval benefits the pediatric patient population and the needs that the therapy might be able to address in the hands of physicians treating these patients.
Mike Davis: This expanded indication of Briviact (brivaracetam) CV to treat partial-onset seizures in patients as young as 1 month of age marks the first time that the IV injection formulation of Briviact will be 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 1 month of age and older in nearly 7 years.
All three Briviact formulations, including tablets, IV and oral solutions, are now indicated for the treatment of partial-onset seizures in pediatric patients 1 month of age and older—further building on UCB’s commitment to creating a better day-to-day experience for people living with severe diseases.
Childhood epilepsy varies in severity and prognosis and may have profound consequences on development and functioning, and seizure burden can impair cognition with effects being most severe in infancy. 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 has epilepsy, we know that their life and the life of their caregiver can be consumed by the unpredictable nature of seizures and the potentially profound consequences epilepsy can have on pediatric patients. At UCB, we leveraged our 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.
Transcript edited for clarity.