UCB have announced the European Commission (EC) has approved BRIVIACT® (brivaracetam) as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization (spreading to both sides of the brain after the initial seizure) in adult and adolescent patients from 16 years of age with epilepsy. BRIVIACT® treatment is initiated without titration, meaning patients receive a therapeutic dose of the drug from the first day of treatment.
"Today's approval from the European Commission is exciting news for those in the EU who suffer from epilepsy and need alternative treatment options," said Jean-Christophe Tellier, UCB's CEO. "One of UCB's key ambitions is improving the lives of people with epilepsy, and we are thrilled to bring BRIVIACT® to patients in Europe and lead the way in making positive changes in how epilepsy is managed."
First launches in EU countries are set to begin this quarter.
Epilepsy is a chronic neurological disorder affecting around 7 million people in Europe.1 Despite currently-available treatments, many patients with epilepsy still experience seizures regardless of using at least one AED.2
"There is an unmet need for epilepsy medicines that effectively control seizures and are also well tolerated by patients," said Dr Manuel Toledo MD, PhD, consultant neurologist and epileptologist at the Vall d'Hebron Hospital, Barcelona, Spain, who participated in the placebo-controlled trials for BRIVIACT®. "A new treatment such as BRIVIACT®, that enables patients to receive a therapeutic dose from the very first day without titration, represents a big step forward to further helping people with epilepsy."
The EC approval is based on pooled data from three pivotal Phase 3 studies (N01252, N01253 and N01358), in which BRIVIACT® demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days (19.5%, 24.4% and 24.0% for BRIVIACT® 50, 100 and 200 mg/day respectively, p4,5 The proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day), vs. 20.3% for placebo (p4,5 BRIVIACT® was generally well tolerated by patients, and the most commonly reported adverse reactions (≥5%) with the drug were somnolence (15.2%), dizziness (11.2%), headache (9.6%) and fatigue (8.7%).4Brivaracetam is also currently under review for approval in other countries including the U.S., Australia, Canada and Switzerland.
Rationally designed and developed by UCB, BRIVIACT® is a selective high-affinity synaptic vesicle protein 2A ligand available in three formulations (film-coated tablets, oral solution and solution for injection/infusion).6 BRIVIACT® can be initiated without titration, meaning patients receive a therapeutic dose of brivaracetam from the first day of treatment. Physicians are also able to adjust dosing up or down depending on patient response and tolerability.
Overall, the BRIVIACT® clinical development program has involved more than 3,000 people and more than eight years of experience for some patients.7
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age. An estimated 7 million people in Europe will have an epileptic seizure at some time during their lives.
Epilepsy is considered to be a disease of the brain defined by any of the following conditions: (1) at least two unprovoked (or reflex) seizures occurring >24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome.