Briviact Approved as Monotherapy for Partial-Onset Seizures

Friday, September 15, 2017

The FDA has approved a supplemental new drug application for Briviact (brivaracetam, UCB) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is the newest antiepileptic drug in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with Briviact for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.

UCB submitted a supplemental application for a Briviact monotherapy indication taking into account a recent General Advice Letter, issued by the FDA,2 which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of POS to their use as monotherapy for the treatment of POS. Briviact has already been approved in the as adjunctive treatment for POS in patients in this age group.

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