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Brussels, Belgium – 31 May, 7:30 AM CET – Today UCB announced that BRIVIACT® (brivaracetam) CV, approved as adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy, is now available in U.S. pharmacies across the country. BRIVIACT® is available in three formulations: film-coated tablets, oral solution and injection. Injection may be used when oral administration is temporarily not feasible. Injection (single-dose vials) will be available in pharmacies in June.
BRIVIACT® is a new molecular entity that was approved by the U.S. Food and Drug Administration (FDA) on February 18, 2016, providing an important new treatment option for those living with epilepsy. On May 12, 2016, the Drug Enforcement Administration (DEA) listed BRIVIACT® as a Schedule V controlled substance.
Gradual dose escalation is not required when initiating treatment with BRIVIACT®. The recommended starting dosage is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
“What It is important to note that with BRIVIACT® is that titration is not required to achieve a therapeutic dose. Patients can start their very first BRIVIACT® treatment with a therapeutic dose. This makes it a useful addition to the current antiepileptic medication armamentarium,” said Dr. Pavel Klein, MD, Director, Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland.
BRIVIACT® is associated with important warnings and precautions including suicidal behavior and ideation, somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including non-psychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema). BRIVIACT® is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.1
Patients with epilepsy are living with significant unmet needs. Approximately 30% of people with epilepsy remain uncontrolled on existing therapies and still experience seizures, which can lead to devastating physical and emotional consequences.2,3 Epilepsy can develop in anyone at any age, and approximately one in 26 people will develop epilepsy in their lifetime.4
“At UCB, we are constantly inspired to improve patients’ lives, which is why we are excited that BRIVIACT® is now available in U.S. pharmacies. This is an important addition to our existing epilepsy portfolio," said Jeff Wren, Head of Neurology and Executive Vice President at UCB. “We remain steadfast in our commitment to addressing unmet needs for people with epilepsy, and will continue our efforts to bring this important treatment to even more patients worldwide.”
In January 2016, the European Commission granted the marketing authorization for BRIVIACT® as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent patients from 16 years of age with epilepsy. In the EU, BRIVIACT® is already available to patients in the UK, Germany, and Denmark. In Canada, brivaracetam is approved as the trade name BRIVLERA®. UCB has submitted additional regulatory applications for brivaracetam in other countries including Australia, Brazil, Russia, Switzerland and Turkey.
About BRIVIACT®
BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).1,5
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Adverse Reactions
The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf
For more information on BRIVIACT®, contact 844-599-CARE (2273).
BRIVIACT® is a registered trademark of the UCB Group of Companies.
About Epilepsy4,6,7,8,9
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 U.S. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age. Approximately one in 26 people will develop epilepsy in their lifetime.
There are many different types of epilepsy, but the main characteristic of the condition is recurrent seizures. Seizures are classified by the pattern of onset—partial seizures start in one part of the brain and generalized seizures are characterized by widespread involvement of the whole brain.
Epilepsy 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 more than 20 years of experience in the research and development of anti-epileptic 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.
For further information
Corporate Communications
France Nivelle,
Global Communications,
T +32 2 559 9178, france.nivelle@ucb.com
Jim Baxter,
Media Relations, UCB
T +32 473 78 85 01, jim.baxter@ucb.com
UCB Investor Relations
Antje Witte,
Investor Relations, UCB
T +32 2 559 94 14, antje.witte@ucb.com
Isabelle Ghellynck,
Investor Relations, UCB
T +32 2 559 9588, isabelle.ghellynck@ucb.com
References
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 in immunology and neurology. With more than 7500 people in approximately 40 countries, the company generated revenue of €3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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