UCB announced on 5/14/18 that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company's newest anti-epileptic drug (AED) Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older.
This approval provides clinicians with the option to prescribe Briviact to their pediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children. Briviact injection has not been established in pediatric patients, and therefore is only indicated for patients 16 years of age or older.
Briviact is the newest anti-epileptic drug (AED) in the synaptic vesicle protein 2A (SV2A) family of medicines - a class of medicines discovered and developed by UCB. BRIVIACT demonstrates a high and selective affinity for SV2A in the brain. It is highly permeable and is rapidly and almost completely absorbed which may contribute to its anticonvulsant effects.
This is another addition to Briviact 's indications. In Sept of 2017, The FDA added an approval for Briviact as monotherapy in adults with partial-onset seizures.