UCB Announces BRIVIACT® (brivaracetam) CV Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older

Aug 30

This Press Release is Intended for Media and Investor Stakeholders Only

Tablets, oral solution, and IV (or intravenous) dosage forms of BRIVIACT® (brivaracetam) CV now FDA-approved as both monotherapy or adjunctive therapy for the treatment of partial-onset seizures in patients one month of age and older.
This is the first time that the IV formulation of BRIVIACT will be available for pediatric patients 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.
• 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

Atlanta, Ga. August 30, 2021 – 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) CV
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. More information is available at www.BRIVIACTHCP.com

BRIVIACT INDICATION AND IMPORTANT SAFETY INFORMATION²
BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
Psychiatric Adverse Reactions: 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.
Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

Dose adjustments are recommended for patients with all stages of hepatic impairment.
When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS
In adult adjunctive therapy placebo-controlled clinical 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. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information.

For additional medical information about BRIVIACT, patient assistance, or any other information please visit our website or call ucbCARES® at 1-844-599-2273.

About Epilepsy
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.

About UCB
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.

For further information, UCB:
U.S. Neurology Communications
Erica Puntel
U.S. Communications, UCB
T 404.938.5359, erica.puntel@ucb.com

Investor Relations
Antje Witte
Investor Relations, UCB
T +32.2.559.94.14, antje.witte@ucb.com

Julien Bayet
Investor Relations, UCB
T + +32-2-559 9580, julien.bayet@ucb.com

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.

References

Data on file. UCB, Inc.
BRIVIACT® [package insert]. Smyrna, GA: UCB Inc.
Cross, H, et al. Advancing the management of childhood epilepsies. European Journal of Pediatric Neurology 2013; http://dx.doi.org/10.1016/j.ejpn.2013.02.003.
Wirrell, E. Infantile, Childhood, and Adolescent Epilepsies. Continuum Review Article. Neurology 2016; 22(1):60-93.
Berg, A, et al. Age at onset of epilepsy, pharmacoresistance, cognitive outcomes. Neurology 2012; 79: 1384-1391.
The Epilepsy Foundation of America. About epilepsy basics. http://www.epilepsy.com/learn/about-epilepsy-basics. Accessed 3 August 2021.
The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 3 August 2021.