FDA Approves UCB’s Epilepsy Drug, Briviact
UCB, a Brussels, Belgium-based biopharmaceutical company, has received approval from the US Food and Drug Administration for Briviact (brivaracetam) as an adjunctive therapy for treating the partial-onset of seizures in patients 16 years of age and older with epilepsy. The Drug Enforcement Administration is anticipated to classify Briviact according to the drug scheduling process within the next 90 days, after which time Briviact will become commercially available in the US.
In January 2016, the European Commission granted marketing authorization for the drug as an adjunctive therapy for treating the partial onset of seizures with or without secondary generalization in adults and adolescents from 16 years of age with epilepsy. UCB has submitted additional regulatory applications in other countries including Australia, Brazil, Canada, Russia, Switzerland, and Turkey.