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Major advance in UCB pipeline: positive topline Phase 3 results for brivaracetam in epilepsy patients with partial-onset seizures
Date:7/23/2014

t 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.

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

The phase 3 clinical development plan for brivaracetam consisted of the following studies:N01252: an evaluation of the efficacy and safety/tolerability of adjunctive brivaracetam 20, 50, and 100 mg/day compared with placebo over 12 weeks, in 399 randomized patients (greater than or equal to 16 to 70 yea
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