UCB Announces Positive Phase III Clinical Results for Brivaracetam
UCB has today announced positive topline clinical results for epilepsy drug, brivaracetam, from their most recent Phase III clinical study.
The aim of clinical trial was to assess the effectiveness of brivaracetam as adjunctive treatment in adults not fully controlled despite treatment with one or two concomitant antiepileptic drugs, in comparison to placebo.
Results of the clinical study demonstrated that the drug reduced partial-onset seizure frequency and improved responder rates.
Iris Loew Friedrich, UCB’s chief medical officer, noted that the results were consistent with previous brivaracetam trials, adding that the recent trial was the largest Phase III clinical study conducted in epilepsy patients with partial-onset seizures.
Loew mentioned that overall “the brivaracetam development programme has involved over 3,000 people and offers over eight years of clinical experience with some patients”, adding that the company “look forward to discussing the data with the regulatory authorities and the scientific community.”
Jean-Christophe Tellier, the company’s chief executive-elect, stated that “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.
As a result of the positive clinical trial results, UCB are planning on submitting a New Drug Application to the US FDA and a Marketing Authorisation Application to the EMA at the start of next year.