A supplemental new drug application for Briviact (brivaracetam) CV as a monotherapy treatment for partial-onset seizures in patients aged 16 years and older with epilepsy received approval from the Food and Drug Administration on Sept. 15, according to an announcement from its manufacturer, UCB.
Brivaracetam is already approved in the United States as an adjunctive treatment for partial-onset seizures in patients in this age group. As a result, adults and adolescents aged 16 years and older with partial-onset seizures in the United States can now be initiated on brivaracetam as monotherapy or adjunctive therapy.
The drug was approved for monotherapy based on the extrapolation of efficacy and safety data from its clinical trials data, which involved more than 2,400 adult patients with partial-onset seizures. FDA rules allow efficacy and safety data for drugs approved as adjunctive therapy for partial-onset seizures to be extrapolated to their use as monotherapy for the condition.
Brivaracetam is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with brivaracetam for monotherapy or adjunctive therapy. According to the prescribing information , it is available in three formulations: film-coated tablets (10-mg, 25-mg, 50-mg, 75-mg, and 100-mg strengths), oral solution (10 mg/mL), and injection (50 mg in a 5-mL single-dose vial).
Common adverse reactions reported in at least 5% of brivaracetam users and at least 2% more frequently than placebo are somnolence and sedation, dizziness, fatigue, and nausea and vomiting.
“This new monotherapy indication builds on an already strong and compelling clinical profile for Briviact, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Pavel Klein, MD, director of the Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Md., in the UCB announcement . “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day 1, Briviact provides an additional treatment choice for neurologists and their patients.”