Expanded FDA approval for Briviact

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for 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 convenient option to prescribe Belgian drugmaker UCB’s (Euronext Brussels: UCB) Briviact to their pediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children.

As a result of the FDA’s decision, children age four years and older with partial-onset seizures in the USA can now be treated with Briviact. This extends the clinical application for BRIVIACT which already has a similar indication for adults.