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FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults

Posted 20 Sep 2017 by Drugs.com

Atlanta, Georgia (U.S.) & Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Briviact (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy.1 This is a new indication for Briviact, which is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. As a result, adults and adolescents aged 16 years and older with POS in the U.S. can now be initiated on Briviact as monotherapy or adjunctive therapy. Briviact is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not ... Read more

Related support groups: Seizures, Epilepsy, Briviact, Brivaracetam

Briviact Approved for Epileptic Seizures

Posted 24 Feb 2016 by Drugs.com

FRIDAY, Feb. 19, 2016 – Briviact (brivaracetam) has been approved by the U.S. Food and Drug Administration to treat partial onset seizures in people aged 16 and older with epilepsy. Partial onset seizures describe those that originate in a limited area of the brain, the FDA said Friday in a news release. Epilepsy, a common disorder believed to affect more than 5 million people in the United States, is characterized by recurring seizures, with typical symptoms including uncontrolled movement, muscle spasms and abnormal behavior. Common causes of epilepsy include stroke, infection, tumors, brain injury and abnormal brain development, the FDA said. In many cases, no cause can be identified, the agency added. Briviact, taken with other medications, was evaluated in clinical studies involving more than 1,500 people. Common side effects included drowsiness, dizziness and nausea. As with ... Read more

Related support groups: Seizures, Epilepsy, Briviact, Brivaracetam

FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures

Posted 24 Feb 2016 by Drugs.com

February 19, 2016 – 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 t ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis, Briviact, Brivaracetam

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