FDA approves UCB’s Briviact

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Briviact (brivaracetam) from Smyrna, Ga.-based UCB. The drug is indicated as an add-on treatment to other medication for partial onset seizures in patients with epilepsy aged 16 years and older. 

 

“Patients can have different responses to the various seizure medicines that are available,” said Dr. Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”

 

The drug must be dispensed with a patient medication guide that explains information about using Briviact and its potential risks, including thoughts of suicide, feelings of agitation, suicide attempts, depression that is new or worsens, aggression and panic attacks.