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Major advance in UCB pipeline: positive topline Phase 3 results for brivaracetam in epilepsy patients with partial-onset seizures

August 6, 2014

By a News Reporter-Staff News Editor at Biotech Week -- regulated information -- 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).(2)

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.(3 )

"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 trials,("4-6) 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 (see also UCB).

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared to placebo, over a 12-week treatment period, in 768 randomized focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs.(2,7) The primary endpoint for the European regulatory authorities is the 50% responder rate for partial-onset seizure frequency compared with placebo, over the treatment period standardized to a 28-day duration. The primary endpoint for the FDA is the percent reduction over placebo for partial-onset seizure frequency, over the treatment period standardized to a 28-day duration.(2) Detailed data from this study will be submitted for presentation at upcoming epilepsy congresses and for publications in peer-reviewed journals.

About brivaracetam and the Phase 3 clinical development program

Discovered and developed by UCB, brivaracetam is a highly selective synaptic vesicle protein 2A ligand.(8,9 )

Keywords for this news article include: UCB, Epilepsy, Seizures, Brain Diseases, Central Nervous System Diseases.

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Source: Biotech Week

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