FDA approves new UCB drug to treat epilepsy-related seizures
- The FDA approved UCB's Briviact (brivaracetam) as an add-on medication for the treatment of partial onset seizures in patients age 16 years and older with epilepsy.
- Epilepsy is the fourth most common neurological disease in the U.S., affecting approximately 2.9 million people in the U.S., and roughly 65 million people worldwide.
- Approval of Briviact stemmed from three phase 3 clinical trials involving 1,550 patients.
Up to 25% of patients with epilepsy are pharmacoresistant, according to a 2014 article in Pharmacy & Therapeutics. This means some patients continue to experience seizures even while using the maximum dose of an approved anti-seizure drug.
Therefore, although there are more than 40 approved anti-seizure drugs, there continues to be an unmet need for new treatment options. This is where Briviact comes in.
“With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option," said Billy Dunn, director of the Division of Neurology Products at the FDA, in a statement.