UCB Submits Approval Application for Investigational Antiepileptic Drug
UCB recently announced that the FDA has accepted for review its New Drug Application for brivaracetam, an investigational treatment for partial-onset seizures in patients aged >16 years with epilepsy.
UCB recently announced that the FDA has accepted for review its New Drug Application (NDA) for brivaracetam, an investigational treatment for partial-onset seizures in patients aged >16 years with epilepsy.
The NDA for brivaracetam was filed following a comprehensive clinical development program that enrolled more than 3000 patients. The program has included 3 phase 3 studies that evaluated the efficacy and safety of 5 to 200 mg/day doses of adjunctive brivaracetam in patients with uncontrolled partial-onset seizures and a fourth phase 3 study that evaluated the safety and tolerability of individualized 20 to 150 mg/day doses of adjunctive brivaracetam in adults with partial-onset seizures.
“Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development,” said UCB Chief Medical Officer and Executive Vice President Iris Loew-Friedrich, MD, in a press release. “It is also an important time for the clinicians and patients whose involvement in brivaracetam clinical trials has been so important in helping us to address the need for new treatment options for adult patients who do not achieve partial-onset seizure control with current antiepileptic drugs.”
There are currently 6 ongoing studies of brivaracetam, many of which are open-label, follow-up studies evaluating the long-term safety and efficacy of the antiepileptic drug.