FDA approves Briviact to treat partial onset seizures

Feb 19, 2016, 08:51 ET from U.S. Food and Drug Administration

SILVER SPRING, Md., Feb. 19, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode, usually of relatively short duration, of abnormal brain activity. Seizures can cause a variety of symptoms, including uncontrolled movements or spasms, abnormal thinking and behavior, and abnormal sensations. Muscle spasms can be violent, and loss of consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial onset seizure begins in a limited area of the brain.

"Patients can have different responses to the various seizure medicines that are available," said Billy Dunn, M.D., 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."

Epilepsy has many possible causes including, among others, stroke, infection, tumors, traumatic brain injury, and abnormal brain development. In many cases, the specific cause is unknown. Epilepsy is one of the most common conditions affecting the brain. Approximately 5.1 million people in the United States have a history of epilepsy and approximately 2.9 million people in the United States have active epilepsy.

Briviact's effectiveness was studied in three clinical trials involving 1,550 participants. Briviact, taken along with other medications, was shown to be effective in reducing the frequency of seizures.

The most common side effects reported by people taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.

Briviact must be dispensed with a Medication Guide for patients, which provides important information about the medication's use and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. Rarely, patients may exhibit an allergic reaction associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing.

Briviact is marketed by UCB, Inc. of Smyrna, Georgia.

For more information:

FDA: Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

FDA: Novel Drug Approvals
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm

Centers for Disease Control and Prevention 
http://www.cdc.gov/epilepsy/basics/faq.htm

National Institute of Neurological Disorders and Stroke: Epilepsy Information
http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

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SOURCE U.S. Food and Drug Administration



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