UCB today announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam. In the US, the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication. Acceptance for review indicates that the FDA and EMA have found the Company's submissions to be sufficiently complete to proceed.  

“Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development. It is also an important time for the clinicians and patients whose involvement in brivaracetam clinical trials has been so important in helping us to address the need for new treatment options for adult patients who do not achieve partial-onset seizure control with current antiepileptic drugs. We look forward to working closely with the FDA and EMA through the review process.” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.

For more details, go to: http://www.ucb.presscentre.com/News/UCB-announces-US-and-EU-regulatory-filings-for-the-investigational-antiepileptic-drug-brivaracetam-4ba.aspx