Epileptic Seizure Treatment Approved By FDA
The U.S. Food and Drug Administration (FDA) has approved Briviact (brivaracetam) for Epileptic Seizure Treatment as an adjunctive therapy (used in addition to a primary therapy) for the Epileptic Seizure Treatment of patients who are at least 16 years old, announced the Belgium-based global biopharma UCB.
“The FDA’s approval of Briviact for Epileptic Seizure Treatment is significant, because uncontrolled seizures can have serious, long-term effects, and approximately 30 percent of epilepsy patients remain uncontrolled on currently available treatments,” Dr. Pavel Klein, director of the Mid-Atlantic Epilepsy and Sleep Center, said in a press release.Briviact for Epileptic Seizure Treatment is a new molecular entity that was rationally designed and developed by UCB. The drug displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which might contribute to the anticonvulsant effect. The precise mechanism by which this happens is not entirely known. Briviact will be commercialized in three formulations: film-coated tablets, oral solution, and injection.
“We are excited to introduce Briviact as a new therapeutic option that may make a difference in the lives of people with epilepsy in the U.S.,” said Jeff Wren, UCB executive vice president and head of neurology. “This approval is the culmination of more than eight years of clinical trials involving more than 2,400 adult patients with partial-onset seizures. The development of Briviact builds upon our longstanding heritage in developing meaningful treatment solutions for people living with epilepsy.”