UCB announces US and EU regulatory filings for the investigational antiepileptic drug brivaracetam

Brussels (Belgium), 21st January 2015 – 0700 (CET) – 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 ...

Brussels (Belgium), 21st January 2015 – 0700 (CET) – 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.

The US NDA and the EU MAA are supported by data from a comprehensive clinical development program including three Phase 3 studies which evaluated the efficacy and safety of adjunctive brivaracetam (5 mg-200 mg/day dose range) in patients with uncontrolled partial-onset seizures.1-3 A supportive fourth Phase 3 study evaluated the safety and tolerability of adjunctive brivaracetam given at individualized tailored doses between 20 and 150 mg/day in adult patients with partial-onset seizures.4

Overall, the brivaracetam clinical development program has involved over 3000 people and over 8 years of experience for some patients.5 There are six on-going studies of brivaracetam.6-11 These are predominantly open-label, follow-up studies to assess long-term safety and efficacy of brivaracetam. Discovered and developed by UCB, brivaracetam is a selective synaptic vesicle protein 2A ligand.12,13

NOTES TO EDITORS

About Epilepsy 14,15,16
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and more than 2 million people in the U.S. It is the fourth most common neurological disorder in the US Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age. Approximately 1 in 26 people will develop epilepsy in their lifetime.

It is considered to be a disease of the brain defined by any of the following conditions: (1) at least two unprovoked (or reflex) seizures occurring >24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome.

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with epilepsy


About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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