Neurology Central

Brivaracetam approved for partial-onset seizures by the US-FDA

UCB today announced approval of brivaracetam (BRIVIACT®) by the US-FDA as an adjunctive therapy in the treatment of partial-onset seizures in epilepsy patients aged 16 years and older. The therapy is already available to patients in the UK & Germany for this indication.

The approval is based on the results of three Phase III studies, in which BRIVIACT® exhibited efficacy over placebo in reducing partial-onset seizure frequency. Adverse reactions occurred at a frequency of approximately 5% in patients with doses of at least 50mg/day, with nausea, fatigue, dizziness and somnolence being the most common. Discontinuation rates were 5%, 8% & 7% for patients randomized to dosage groups of 50mg, 100mg & 200mg/day respectively. This is in comparison to a 4% discontinuation rate in the placebo group.

BRIVIACT® is a novel molecular entity that displays a high affinity for the synaptic vesicle protein 2A. The precise mechanism of action which contributes to the anticonvulsant activity however remains unknown.

Jeff Wren of UCB commented: “We are excited to introduce BRIVIACT® as a new therapeutic option that may make a difference in the lives of people with epilepsy in the U.S. This approval is the culmination of more than eight years of clinical trials involving more than 2400 adult patients with partial-onset seizures. The development of BRIVIACT® builds upon our longstanding heritage in developing meaningful treatment solutions for people living with epilepsy.”

“The FDA’s approval of BRIVIACT® is significant, because uncontrolled seizures can have serious, long-term effects, and approximately 30% of epilepsy patients remain uncontrolled on currently available treatments,” commented Dr Pavel Klein (Mid-Atlantic Epilepsy and Sleep Center; MD, USA).

Source: UCB press release