BRUSSELS and ATLANTA, Dec. 3, 2021 /PRNewswire/ -- 1:30 p.m. ET: UCB today announced that new data from its seizure treatment portfolio (BRIVIACT, NAYZILAM, and VIMPAT) will be showcased at the 75th American Epilepsy Society Annual Meeting (Chicago, Illinois), December 3-7, 2021. Further insightful data on the management of epilepsy will also be presented, including the burden of untreated and treated epilepsy and research into health inequities.
"For approximately 30 years, we have provided options that have helped transform the treatment landscape and improved the lives of millions of people living with epilepsy, and we're excited to present new data at this congress from our ongoing comprehensive research program," said Charl van Zyl, executive vice president neurology & head of Europe/International Markets at UCB. "We have a commitment to redefine the future of epilepsy medicine, and this congress is a special moment for us to connect with the community and healthcare professionals and share our ambitions."
At the congress, UCB will be reporting data from several significant clinical and population health epilepsy studies. These data include the efficacy and tolerability of BRIVIACT in children and adolescents with partial-onset seizures and real-world evidence studies. Posters also include the early use of NAYZILAM in patients with seizure clusters and the long-term efficacy and tolerability of adjunctive VIMPAT for the treatment of primary generalized tonic-clonic seizures (PGTCS). Just recently, the FDA approved an expanded indication for both BRIVIACT and VIMPAT tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.1,2
UCB will also host a scientific exhibit, "UCB, Leading with Science: From Established Therapies to New Approaches" on Sunday, December 5th, 8:00 - 11:00 a.m., in McCormick Place West, Level 4, Room W474a, to provide attending healthcare professionals an opportunity to engage around UCB's epilepsy research, as well as to provide updates on clinical data and more information about clinical-studies recruiting.
Addressing health inequities in epilepsy management
Alongside scientific presentations, UCB will facilitate a satellite symposium exploring the cultural drivers in healthcare decision-making. In this session, thought leaders on the Hispanic experience of healthcare will share current thinking and research about how health professionals may optimize care delivery and address health inequities for Hispanic populations living with epilepsy. The symposium will cover Hispanic American culture and attitudes to healthcare, the impact of stigma, and implications for providers. The symposium - entitled "Addressing health inequities for over 700,000 people with epilepsy: improving the experience and outcomes for Hispanics in the U.S." - is hosted by Joseph Sirven, MD, professor of neurology and editor-in-chief of epilepsy.com, Mayo Clinic. Registered delegates can attend the symposium, December 3, 6:00–8:00 p.m., McCormick Place West Building (Room W190 A/B). The symposium will include an esteemed panel of speakers including: Lidia Moura, MD, MPH, assistant professor of neurology, Harvard Medical School, assistant in neurology, Massachusetts General Hospital; Jesus Eric Pina-Garza, MD, professor of neurology and pediatrics, director of pediatric epilepsy, the Children's Hospital at TriStar Centennial; Fabian Sandoval, MD, CEO & research director, Emerson Clinical Research Institute. Inc.; Iris Loew-Friedrich, MD, PhD, executive vice president & chief medical officer, UCB; and Grant Simic, BMedSci CPHQ, executive population health partner, U.S. neurology, UCB.
Mike Davis, Head of U.S. Neurology at UCB, comments: "It is our ambition to tackle the everyday barriers people living with epilepsy face, including access to care. Hispanics are the single largest subpopulation of people living with epilepsy in the U.S., yet data shows that Hispanic patients are disproportionately impacted by cultural, socioeconomic, and language challenges that can impede access to care. UCB is helping to address these health inequities by providing culturally relevant resources on epilepsy and our medications, which can hopefully improve this gap in epilepsy care."
UCB-sponsored poster presentations at the 75th American Epilepsy Society (AES 2021) Annual Meeting include the following:
- Cognitive and Behavioral Effects and Tolerability of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Pooled, Interim Analysis. Elshoff J-P, Fleyshman S, De La Loge C, Nondonfaz X, Reichel C, Floricel F, Smeyers P
- Time Course of Treatment Emergent Adverse Events Potentially Associated with Behavioral Disorders During Adjunctive Brivaracetam Treatment of Adults with Focal Seizures. Dimova S, Klein P, Laloyaux C, Nondonfaz X, Floricel F, Elmoufti S, Meador K
- Real-world Study of Brivaracetam in the United States. Dave H, French J, Altalib H, Henninger H, Porter R, Gelfand M, Martin M, Dongre P, Elmoufti S, Schulz A, Sperling M
- Effectiveness and Tolerability of Brivaracetam by Reason for Initiation in Adults with Focal Seizures: Post Hoc Analysis of a Real-world, US Study. Henninger H, Sperling MR, Altalib H, Dave H, Gelfand M, Porter R, Martin M, Elmoufti S, Schulz AL, Dongre P, French J
- Patient-reported Outcomes in Mood, Fatigue, Sleep Disturbance, and Disability While on Brivaracetam Treatment: a Prospective Observational Study. Altalib H, French J, Sperling M, Henninger H, Dave H, Gelfand M, Schulz A, Elmoufti A, Dongre P, Martin M
- Early Intervention with Midazolam Nasal Spray and Efficacy in Patients With Seizure Clusters: Post Hoc Analysis of an Open-label Extension Trial. Wheless JW, Brunnert M, Floricel F, Dimova S, Fannon B
- Long-term Efficacy and Tolerability of Adjunctive Lacosamide for the Treatment of Primary Generalized Tonic-clonic Seizures in Patients by Maximum Dose Used: Interim Post Hoc Analysis. O'Brien TJ, Vossler DG, Farkas KM, Dimova S, Steiniger-Brach B, McClung C, Williams P, Roebling R, Watanabe M
- Evaluating the Occurrence of Newly Diagnosed Health Conditions Among Pediatric Patients Exposed to Intravenous Lacosamide Using Real World Data. Roebling R, Kaur M, Utidjian L, Abend N, Dickinson K, Maltenfort M, Yuen N, Williams P, McDonald J, Kalilani L, McClung C, Foskett N, Forrest C
General Epilepsy Posters
- Hispanic CARE (Cultural Attitudes Regarding Epilepsy): Patient, Caregiver, and Community Perspectives. Simic G, Hansbrough K, Thompson J, Deegan C, Olabarrieta Y, Ennis A
- Hispanic CARE (Cultural Attitudes Regarding Epilepsy): Health Care Stakeholder Perspectives. Ennis A, Thompson J, Simic G
- Health Burden of Untreated and Treated Epilepsy. Chen Z, Ren T, Sharma S, Rychkova M, Dunne J, Lee J, Laloyaux C, Lawn N, Kwan P
- How Often Do Patients with a New Epilepsy Diagnosis Remain Untreated? Decker B, Schriver E, Fischbein K, Smith D, Moyer J, Mowery D, Litt B, Ellis C, Hill C
- Using Design Thinking to Reimagine the Community Pharmacist's Role in Epilepsy Care. White HS, Zaraa S, Stergachis A, Simic G, Protos C, Ricafort L, Bacci JL
- Antiseizure Medication Shortages are Associated With Increased Product Switching: an Analysis of Levetiracetam. Welton J, Stratton G, Schoeninger B, Low MH, Moody A, D'Souza W
Epilepsy is a common neurological condition worldwide and affects approximately 50 million people.3 Epilepsy and seizures can develop in any person at any age,4 and is usually diagnosed after a person has had at least two seizures (or after one seizure with a high risk for more) that were not caused by some known medical condition.5
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.
UCB, Brussels, Belgium (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 8 000 people operating in more than 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
About VIMPAT (lacosamide) CV1
VIMPAT® was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. VIMPAT was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. In 2020, it was approved adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older. In October 2021, VIMPAT received an expanded indication to treat partial-onset seizures in patients as young as one month of age. VIMPAT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.
VIMPAT IMPORTANT SAFETY INFORMATION
VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.
In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%).
Primary Generalized Tonic-Clonic Seizures
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.
Adverse reactions reported in clinical studies for partial-onset seizures in patients 1 month to less than 17 years of age and for primary generalized tonic-clonic seizures for patients 4 to less than 17 years of age were similar to those seen in adult patients.
In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial- onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients.
VIMPAT is a Schedule V controlled substance.
Please refer to the full Prescribing Information and visit VIMPAThcp.com.
About BRIVIACT® (brivaracetam) CV2
BRIVIACT was approved in the U.S. in 2016 as an add-on therapy for adult patients with partial-onset seizures. 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. In August 2021, BRIVIACT was approved for the treatment of partial-onset seizures in patients as young as one month of age. BRIVIACT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection. More information is available at Drugs@FDA: FDA-Approved Drugs.
BRIVIACT IMPORTANT SAFETY INFORMATION
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. 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 in adult and pediatric patients. 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.
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.
About NAYZILAM® (midazolam) nasal spray, CIV6
NAYZILAM is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older.
NAYZILAM IMPORTANT SAFETY INFORMATION
NAYZILAM is contraindicated in patients with acute narrow-angle glaucoma.
RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines, including NAYZILAM, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
ABUSE, MISUSE, AND ADDICTION
The use of benzodiazepines, including NAYZILAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing NAYZILAM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.
DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF NAYZILAM MORE FREQUENTLY THAN RECOMMENDED
The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although NAYZILAM is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of NAYZILAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM.
Risks of Cardiorespiratory Adverse Reactions
Serious cardiorespiratory adverse reactions have occurred after administration of midazolam. Warn patients and caregivers about the risks of respiratory depression, cardiac and respiratory arrest.
Respiratory depression was observed with the administration of NAYZILAM during clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was not reported during clinical trials.
Central Nervous System Depression from Concomitant Use with Other Central Nervous System Depressants, or Moderate or Strong CYP3A4 Inhibitors
Drug products containing midazolam, including NAYZILAM, have a central nervous system (CNS) depressant effect.
Risks from Concomitant Use with Other CNS Depressants
NAYZILAM may cause an increased CNS-depressant effect when used with alcohol or other CNS depressants (e.g., opioids). Warn patients and caregivers that the use of NAYZILAM in combination with alcohol or other CNS depressant drugs may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors
Concomitant use of NAYZILAM with moderate or strong CYP3A4 enzyme inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. Caution patients against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle or riding a bicycle until they have completely returned to their level of baseline functioning.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with NAYZILAM for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.
Impaired Cognitive Function
Midazolam, including NAYZILAM, is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Counsel patients on when they can engage in activities requiring complete mental alertness, operate hazardous machinery, or drive a motor vehicle after taking NAYZILAM.
Benzodiazepines, including NAYZILAM, can increase intraocular pressure in patients with glaucoma. NAYZILAM may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. NAYZILAM is contraindicated in patients with narrow-angle glaucoma.
In the randomized, double-blind, placebo-controlled trial, the most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.
NAYZILAM is a Schedule IV controlled substance.
Please refer to the full Prescribing Information.
For additional medical information about NAYZILAM, patient assistance, or any other information please visit our website or call ucbCARES at 1-844-599-2273.
BRIVIACT®, NAYZILAM®, and ucbCARES® are registered trademarks of the UCB Group of Companies.
VIMPAT® is a registered trademark used under license from Harris FRC Corporation.
©2021 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-P-BR-EPI-2100002
Forward looking statements UCB
This press release contains forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or 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 or within expected timing, 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, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, 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. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB' efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.
Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.
UCB is providing this information, including forward-looking statements, only 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 or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
For further information:
- VIMPAT (lacosamide) CV. U.S. Prescribing Information.
- BRIVIACT (brivaracetam) CV. U.S. Prescribing Information.
- Meyer AC, Dua T, Ma J, et al. Global disparities in the epilepsy treatment gap: a systemic review. Bull World Health Organ. 2010; 88: 260-266
- Epilepsy Foundation. Who gets epilepsy? Available at: https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. (Last accessed: November 2021).
- Epilepsy Foundation : About Epilepsy : the basics. Available at: https://www.epilepsy.com/learn/about-epilepsy-basics (Last accessed: November 2021).
- NAYZILAM (midazolam) nasal spray CIV. U.S. Prescribing Information.
View original content to download multimedia:
SOURCE UCB, Inc.