14 May 2018 - Indication comes less than 2 years after the launch of Briviact in the U.S., building on existing adult monotherapy and adjunctive therapy indications, and broadening clinical application for UCB’s newest anti-epilepsy drug.

UCB announced today that the U.S. FDA has approved a supplemental new drug application for the company’s newest anti-epileptic drug 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.

The expanded FDA indication for Briviact is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. Adverse reactions in paediatric patients are generally similar to those seen in adult patients. This principle of extrapolating clinical data from well controlled studies in adults has been recognised by the FDA as potentially addressing the challenge of limited paediatric data availability.

Read UCB press release