Major advance in UCB pipeline: positive topline Phase 3 results for brivaracetam
UCB announced an important advance in its research and development pipeline with positive topline results from the latest Phase 3 study with brivaracetam. This study was designed to evaluate the efficacy and safety of brivaracetam (100 and 200 mg/day, without titration) compared to placebo, as adjunctive treatment in adult focal epilepsy patients with partial-onset seizures, not fully controlled despite treatment with one or two concomitant antiepileptic drugs (AEDs).
Results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates, both with statistical significance. The most commonly reported adverse events were somnolence, dizziness, fatigue and headache.
“Today’s positive results with brivaracetam represent a significant milestone in our strategy to deliver new treatment options for people with severe diseases. As the newest product to emerge from our late-stage pipeline, brivaracetam is leading the way for UCB’s new era of patient-centric solutions,” said Jean-Christophe Tellier, CEO-Elect, UCB. “We are proud to provide AED options for the epilepsy community today, and remain committed to addressing the unmet needs of adult patients who continue to experience uncontrolled seizures.”
“The positive data from the most recent Phase 3 study demonstrated robust and clinically relevant seizure reduction in predominantly treatment resistant patients, and tolerability was consistent with previous brivaracetam trials4-6,” said Professor Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, UCB. “This study was the largest Phase 3 study conducted in epilepsy patients with partial-onset seizures. Overall, the brivaracetam development program has involved over 3,000 people and offers over eight years of clinical experience with some patients.1 We look forward to discussing the data with the regulatory authorities and the scientific community.”
Based on the results of the brivaracetam Phase 3 program, UCB plans to submit a New Drug Application to the US Food & Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2015.
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