FDA Clears New Medicine Briviact (brivaracetam) for Partial-Onset Seizures
A new medicine has been approved by The US Food and Drug Administration (FDA) as an add-on treatment for partial onset seizures (POS) in patients age 16 years and older with epilepsy -brivaracetam (Briviact, UCB Inc).
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 and can cause a variety of symptoms, such as 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.
According to FDA, an estimated 5.1 million people have a history of epilepsy and roughly 2.9 million people have active epilepsy in the United States as compared in the UK where there are 600,000 (or one in 100) people with epilepsy and the number of cases is increasing partly as a result of the ageing population.
More about Briviact
Billy Dunn, MD, the director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, stated in a press conference, “Patients can have different responses to the various seizure medicines that are available. With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”
Brivaracetam is an anti-epileptic drug (AED) that provides patients with POS a new opportunity to better manage their seizures. It is a selective, high-affinity synaptic vesicle protein 2A ligand and an analogue of the already available antiepileptic drug levetiracetam. It was studied in three clinical trials involving 1550 participants and it was noted that when taken along with other medications, the drug was effective in reducing the frequency of seizures.
The most common side effects reported by those people who have been taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.
It must be emphasized that this drug is to be dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks since 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. In rare cases, the patients may exhibit an allergic reaction associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing, the FDA added.
Briviact is marketed by UCB, Inc. of Smyrna, Georgia. Brivaracetam has also been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as adjunctive therapy for partial-onset seizures with or without secondary generalization in adult and adolescent patients 16 years of age and older with epilepsy.