BioCentury
ARTICLE | Clinical News

Briviact brivaracetam regulatory update

February 29, 2016 8:00 AM UTC

FDA approved Briviact brivaracetam from UCB as an adjunct therapy to treat partial-onset seizures in epileptics ages >=16. UCB plans to launch Briviact after the U.S. Drug Enforcement Administration schedules the drug, which the company expects to occur within 90 days. UCB declined to disclose the company’s pricing plans. FDA required that Briviact be dispensed with a medication guide detailing its risks, which UCB said include suicidal behavior and ideation, neurological and psychiatric adverse reactions and hypersensitivity. ...