FDA Approves Broader Briviact Use in Epilepsy Patients

FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. It is in the “racetam” drug class, which shows a “high and selective affinity for synaptic vesicle protein 2A in the brain” to potentially contribute to anticonvulsant effects, UCB says.

The company says its supplemental NDA relied on an FDA General Advice Letter, which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for treating POS to its use as monotherapy for the condition. “As a result of the FDA’s approach to assessing extrapolated data, UCB was able to support its Briviact monotherapy submission with a wealth of brivaracetam clinical trials data, which involved more than 2,400 adult patients with POS,” it says.