FDA Approves UCB's Briviact To Treat Partial Onset Seizures During Epilepsy

(RTTNews) - The U.S. FDA has approved Briviact (brivaracetam), marketed by UCB, Inc., as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. FDA said, Briviact, taken along with other medications, was shown to be effective in reducing the frequency of seizures. Briviact's effectiveness was studied in three clinical trials involving 1,550 participants.

BRIVIACT, developed by UCB, displays a high and selective affinity for synaptic vesicle protein 2A in the brain, which may contribute to the anticonvulsant effect. However, the company said the precise mechanism of action by which BRIVIACT exerts its anticonvulsant activity is not known. BRIVIACT will be available in three formulations: film-coated tablets; oral solution; and injection. The most common side effects in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.

In January 2016, the European Commission granted the marketing authorization for BRIVIACT as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent patients from 16 years of age with epilepsy. In the EU, BRIVIACT is currently available to patients in the UK and Germany.

UCB, Brussels, Belgium is a global biopharmaceutical company, which has more than 20 years of experience in the research and development of anti-epileptic drugs. The company is listed on Euronext Brussels.