FDA approves Briviact(brivaracetam) as adjunctive therapy for partial-onset seizures- UCB

UCB has announced that the FDA has approved Briviact (brivaracetam) as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset 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 U.S.

The approved indication is based on data from three pivotal Phase III studies (Studies N01252, N01253 and N01358), in which Briviact demonstrated efficacy over placebo in reducing partial-onset seizure frequency during the treatment period. The most common adverse reactions occurring at a frequency of at least 5% in patients treated with Briviact doses of at least 50 mg/day and greater than placebo were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. The discontinuation rate due to adverse events was 5%, 8%, and 7% for patients randomized to receive Briviact at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, compared to 4% in patients randomized to receive placebo.

Comment: 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 already available to patients in the UK and Germany. UCB has submitted additional regulatory applications for brivaracetam in other countries including Australia, Brazil, Canada, Russia, Switzerland and Turkey.