UCB announced that the Food and Drug Administration (FDA) has approved Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures in patients aged ≥16 years with epilepsy. Briviact was initially approved as adjunct treatment for partial-onset seizures. 

The supplemental New Drug Application (sNDA) approval was based on the FDA guidance that allows for extrapolation of the safety and efficacy of drugs approved as adjunctive therapy for the treatment of partial-onset seizures. The sNDA submitted to support the monotherapy indication included clinical data involving over 2400 adults with partial-onset seizures.

Briviact, a CV controlled substance, works through high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain. It is available in three formulations: film-coated tablets, injection, and oral solution. 


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Briviact is supplied as 10mg, 25mg, 50mg, 75mg, and 100mg strength tablets; a 10mg/mL strength oral solution; and as a 50mg/5mL strength solution for intravenous (IV) injection.

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Reference

New indication for BRIVIACT® (brivaracetam): UCB’s newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults [press release]. Atlanta, GA: UCB. https://www.ucb.com/stories-media/Press-Releases/article/New-indication-for-BRIVIACT-brivaracetam-UCB-s-newest-antiepileptic-drug-approved-by-FDA-as-monotherapy-treatment-of-partial-onset-seizures-in-adults. Published September 15, 2017. Accessed September 19, 2017.

This article originally appeared on MPR