ATLANTA, Aug. 30, 2021 /PRNewswire/ — UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.2 This is the first time that the IV formulation of Briviact will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly 7 years.
Childhood epilepsy varies in severity and prognosis and may have profound consequences on development and functioning.3,4 Seizure burden can impair cognition with effects being most severe in infancy.4,5 Despite these elevated challenges, few antiseizure medications are FDA-approved for treating partial-onset seizures in this vulnerable patient population.
“When a child or infant suffers from epilepsy, we know that their life and the life of their caregiver is consumed by the unpredictable nature of seizures and the potentially profound consequences epilepsy can have on pediatric patients,” said Mike Davis, Head of U.S. Neurology at UCB. “We’ve leveraged UCB’s experience in epilepsy and commitment to innovation to expand the indication for Briviact to reduce the number of partial-onset seizures these young and vulnerable patients are experiencing and provide their caregivers with an FDA-approved treatment.”
Briviact data in pediatric patients includes long-term retention rates over 2 years. In an open label follow-up pediatric study, an estimated 71.4% and 64.3% of patients, aged 1 month < 17 years with partial-onset seizures (n=168), remained on treatment with Briviact at 1 and 2 years, respectively.1
“We often see children with seizures hospitalized, so it’s important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” said Raman Sankar, MD, PhD, FAAN, FAES, Distinguished Professor and Chief of Pediatric Neurology at the Rubin Brown Endowed Chair for the David Geffen School of Medicine at UCLA and UCLA Mattel Children’s Hospital. “Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as one month, we have a new option that helps meet a critical need in pediatric epilepsy.”
“The pediatric safety and tolerability data for Briviact and the FDA-approved indication for treating partial-onset seizures in children as young as one month supports clinical decision-making for healthcare providers,” said John J. Millichap, MD, FAAN, FAES, Pediatric Epileptologist and Adjunct Associate Professor of Neurology at Northwestern University Feinberg School of Medicine. “In a patient population undergoing brain development and growth, safety and tolerability is a top concern.”
Briviact has an established safety and tolerability profile in adults. Behavior-related adverse events were not commonly reported in adult trials. The most common adverse reactions (at least 5% for Briviact and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. In the pediatric Briviact trials, the safety profile for pediatric patients was found to be similar to that of adults.2
Briviact causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of Briviact compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking Briviact discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.2
About Briviact (brivaracetam)
Briviact was approved in the U.S. in 2016 as an add-on therapy for adult patients. Briviact was approved as monotherapy for adults in September 2017, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2018. Briviact is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.
Epilepsy is a chronic neurological disorder of the brain.6 It is the fourth most common neurological condition worldwide and affects approximately 65 million people.7 Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.7
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 30 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.
UCB (www.ucb-usa.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 7,600 people in approximately 40 countries, the company generated revenue of € 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
Forward looking statements – UCB
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.
UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
SOURCE UCB, Inc.
Posted: August 2021
- UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients – May 14, 2018
- FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults – September 15, 2017
- FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures – February 19, 2016
- UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam – January 21, 2015
Briviact (brivaracetam) FDA Approval History
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