UCB presents latest research at 2018 American Epilepsy Society Annual Meeting demonstrating neurology commitment and leadership |
Brussels (Belgium) & Atlanta, Georgia (USA), November 30 2018, 07:00 (CET): UCB is excited to be presenting 20 abstracts at this year’s American Epilepsy Society Meeting, taking place between November 30 and December 4 in New Orleans, Louisiana. Posters further describing VIMPAT® (lacosamide) CV and BRIVIACT® (brivaracetam) CV clinical data, alongside preliminary data on UCB’s developmental drug candidate for epilepsy, padsevonil*, are scheduled for presentation during the meeting. In collaboration with Proximagen, UCB will be sharing 2 posters describing long term safety and efficacy of Midazolam Nasal Spray, a developmental medicine currently being reviewed by the FDA for the treatment of Seizure Clusters*. UCB acquired Midazolam Nasal Spray from Proximagen in June 2018. Additionally, UCB will share data about non-product specific research alongside our commitments to innovation in the field of epilepsy. These include posters describing UCB’s eliprio™ suite of predictive analytics tools which aim to support the epilepsy community in harnessing data and machine learning to help identify patients who are at high risk of failing through multiple AED treatments and to support improved AED treatment selection. UCB will also be organising a ‘Commitment to Epilepsy Care’ scientific exhibit during AES, where there will also be a clinical trial information desk. This will provide attending healthcare professionals and researchers an opportunity to learn more about UCB’s epilepsy research, clinical studies currently recruiting, and the company’s unique Inspired by Patients, Driven by Science approach to medicines development and discovery. “We’re pleased to be presenting a wide range of data at this year’s American Epilepsy Society meeting, demonstrating our commitment to finding solutions for people with epilepsy, that are driven by science, and aim to help them live their best lives,” explained Mike Davis, Head of US Neurology, UCB. “Our commitment to delivering what patients with epilepsy value is demonstrated through our continuing innovation, exploration of new technologies and solutions, and programs to support patients on their unique journey.” The AES annual meeting is the largest gathering in the world focusing on epilepsy. The meeting brings together professionals in academia, clinical practice, industry, and advocacy to exchange ideas, learn about clinical information and to focus on supporting patients with epilepsy and seizure disorders. “Throughout UCB’s 90-year journey, innovation and agile entrepreneurship have always been essential components in our company’s DNA. In this mindset, we continue to progress patient centric, innovative advances for the treatment of epilepsy,” explained Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “It’s an honor and a privilege to be able to share our research with the Global epilepsy community. By engaging with patients and stakeholders, and listening to their comments, feedback and first-hand experiences, we’re confident we can make a real difference to the millions of people around the world looking for support in managing their epilepsy.” The UCB congress exhibit will also be open throughout the AES congress and is located within the main exhibition hall from November 30 – December 4, Booth 709. The UCB scientific exhibit ‘Commitment to Epilepsy’ will take place Monday, December 3 8:00 AM – 5:00 PM in the Convention Center, Room 282, Second Floor. The following UCB abstracts have been accepted for presentation at AES 2018: Lacosamide related abstracts: 1. Efficacy and tolerability of lacosamide and controlled-release carbamazepine monotherapy in patients with cerebrovascular epilepsy etiology: post hoc analysis of a randomized double-blind trial. Authors: Reetta Kälviäinen, Ali Bozorg, Svetlana Dimova, Ying Zhang, Björn Steiniger-Brach, Bruno Ferrò, Felix Rosenow. Poster # 1.290 -Poster session 1, Saturday December 1, 2018. 2. Long-term safety and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy. Authors: Elinor Ben-Menachem, Hans Peter Grebe, Kiyohito Terada, Lori Jensen, Ting Li, Marc De Backer, Teresa Gasalla, Melissa Brock, Victor Biton. Poster # 1.291 -Poster session 1, Saturday December 1, 2018. 3. Healthcare resource utilization and cost before and after adding lacosamide as adjunctive therapy among patients diagnosed with epilepsy: a retrospective US claims analysis. Authors: David M Labiner, Barbara Johnson, Melinda Martin, Jesse Fishman, Carolyn Lew. Poster # 2.258 -Poster session 2, Sunday December 2, 2018. Brivaracetam related abstracts: 4. Long-term retention on adjunctive brivaracetam in adults with focal seizures previously exposed to carbamazepine, lamotrigine, levetiracetam, or topiramate: a post hoc analysis. Authors: Melinda Martin, Svetlana Dimova, Sami Elmoufti, Cédric Laloyaux, Steve Chung. Poster # 1.294 -Poster Session 1, Saturday December 1, 2018. 5. Behavioral and cognitive effects of long-term adjunctive brivaracetam in children with epilepsy. Authors: Lieven Lagae, Teresa Gasalla, Simon Borghs, Melinda Martin, Jody M Cleveland, Vincent Badalamenti, Jan-Peer Elshoff, Jesus Pina-Garza. Poster # 1.292 -Poster session 1, Saturday December 1, 2018. 6. Long-term effectiveness of adjunctive brivaracetam in children with epilepsy: pooled analysis of data from two open-label trials. Authors: Teresa Gasalla, Melinda Martin, Sami Elmoufti, Vincent Badalamenti, Jan-Peer Elshoff, Anup Patel. Poster # 1.293 -Poster session 1, Saturday December 1, 2018. 7. Efficacy and safety of IV brivaracetam as a treatment for increased seizure activity in an Epilepsy Monitoring Unit. Authors: Jerzy Szaflarski, Ahmed Sadek, Bernhard Greve, Paulette Williams, Julie Varner, Brian Moseley. Late breaking abstract, Abstract ID: 2.464 – Poster session 2, Sunday December 2, 2018 Non-product specific abstracts: 8. Longitudinal predictors of healthcare use in adults with epilepsy. Authors: Jesse Fishman, Boris Vabson, Andrew Wilner. Poster # 1.331-Poster Session 1, Saturday December 1, 2018. 9. Predictors of epilepsy among the young. Authors: Boris Vabson, Hyunmi Kim, Jesse Fishman. Poster # 1.328 -Poster session 1, Saturday December 1, 2018. Eliprio™ related abstracts: 10. Treatment decision support systems (TDSS) in epilepsy –exploring proxy validity and overall clinical outcome success related to TDSS-predicted antiepileptic drug (AED) choices. Authors: Edward Han-Burgess, Ali Bozorg, John D Hixson, Bosny Pierre-Louis, Shweta Joshi, Stephen Yates. Poster # 1.323 -Poster session 1, Saturday December 1, 2018. 11. Adequacy of patient information in electronic medical records and claims sources –an exploratory, retrospective record review to guide development of an antiepileptic drug treatment decision support system (TDSS). Authors: John D Hixson, Stephen Yates, Bosny Pierre-Louis, Robert Warnock, Edward Han-Burgess, Shweta Joshi, Jonathan Williams, Marla Gorges, Steven Vandamme, Joseph Robertson, Ali Bozorg. Poster # 1.324 -Poster session 1, Saturday December 1, 2018. 12. Predicting drug-resistant epilepsy (DRE) –use of big data from administrative claims and machine-learning models. Authors: Cynthia Dilley, Brandon Westover, Joseph Robertson, Jeffrey N Valdez, Sungtae An, Edward Han-Burgess. Poster # 1.325 -Poster session 1, Saturday December 1, 2018. 13. A machine learning approach for developing antiepileptic drug treatment decision support systems (TDSS). Authors: Joseph Robertson, Edward Han-Burgess, Cynthia Dilley, Chris Clark, Jeffrey N Valdez. Poster # 1.326 -Poster session 1, Saturday December 1, 2018. 14. Impact of psychiatric and substance use disorder comorbidity on treatment success among patients with epilepsy –retrospective analysis of claims data. Authors: Jon Duke, Eun Jung Choi, Edward Han-Burgess. Poster # 1.327 -Poster session 1, Saturday December 1, 2018. Padsevonil* related abstracts: 15. Padsevonil differs from brivaracetam and levetiracetam in its interaction with the synaptic vesicle 2A (SV2A) protein. Authors: Martyn Wood, Michel Gillard. Poster # 2.225 -Poster session 2, Sunday December 2, 2018. 16. Protective effects of padsevonil in chronic models of focal and generalized epilepsies with spontaneous recurrent seizures. Authors: Rafal M Kaminski, Karine Leclercq. Poster # 2.224 -Poster session 2, Sunday December 2, 2018. 17. No impact of P-glycoprotein on the brain distribution of padsevonil. Authors: Hugues Chanteux, Hélène Chapy, Judith Van Asperen, Kenneth Saunders, Rafal M Kaminski, David Sciberras. Poster # 2.226 -Poster session 2, Sunday December 2, 2018. 18. Dissecting the heterogeneous clinical response to padsevonil in adults with drug-resistant focal seizures: post hoc responder analysis of a proof-of-concept trial. Authors: Wim Van Paesschen, Manuel Toledo, Christian Brandt, Bernhard J Steinhoff, Marian Majoie, Paul Boon, Elizabeth Webster, Steven De Bruyn, Konrad J Werhahn, Pierandrea Muglia, Andreja Avbersek, Christian Otoul. Poster # 1.289 -Poster session 1, Saturday December 1, 2018. * Padsevonil is an investigational drug candidate for epilepsy currently in clinical development. Additionally, the following posters describing Midazolam Nasal Spray* will be presented by Proximagen at the 2018 AES Meeting: 19. Long-term efficacy experience of Nayzilam® (USL261; Midazolam Nasal Spray) for outpatient treatment of seizure clusters: efficacy results from the open-label, Phase III extension study ARTEMIS-2. Authors: Tze-Chiang Meng, David J. Sequeira, Peter J. Van Ess, William E. Pullman. Poster # 2.235, Poster Session 2, Sunday December 2, 2018 20. Long-term safety experience of Nayzilam® (USL261; Midazolam Nasal Spray) in subjects with seizure clusters: safety results from the open-label, Phase III extension study ARTEMIS-2. Authors: David J. Sequeira, Tze-Chiang Meng, William E. Pullman, Peter J. Van Ess. . Poster # 2.236, Poster Session 2, Sunday December 2, 2018 * Midazolam Nasal Spray has not been approved by the FDA. These statements solely reflect the opinions of the authors. About VIMPAT® (lacosamide): 21,22 In the U.S., VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT® injection in pediatric patients has not been established, VIMPAT® injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older). VIMPAT® was approved in the U.S. in 2008 as an add-on therapy for adult patients. 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. VIMPAT® is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection. Important safety information about VIMPAT® in the U.S. is available below. In Asia, VIMPAT® is available in Hong Kong, Malaysia, Philippines and Thailand, and was approved for use in Japan in 2016, where the product will be jointly commercialised by Daiichi Sankyo. VIMPAT® is not approved in China. Important safety information about VIMPAT® is available below: VIMPAT® (lacosamide) CV U.S. Indication and Important Safety Information INDICATION As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older). WARNINGS AND PRECAUTIONS
PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrhythmia Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible. In the postmarketing setting, there have been reports of cardiac arrhythmias in patients treated with VIMPAT, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death. Most, although not all, cases have occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval. These events have occurred with both oral and intravenous routes of administration and at prescribed doses as well as in the setting of overdose. Vimpat should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome). VIMPAT should also be used with caution in patients on concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenance dose, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Atrial Fibrillation and Atrial Flutter
Adverse Reactions
Dosing Considerations VIMPAT injection is for intravenous and adult use only when oral administration is temporarily not feasible. The loading dose for adult patients should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions. The safety of VIMPAT injection and the use of a loading dose in pediatric patients have not been studied. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment. VIMPAT is a Schedule V controlled substance. Please refer to full Prescribing Information available at www.VIMPATHCP.com. Important Safety Information about VIMPAT® in the EU and EEA About BRIVIACT® (brivaracetam) 23,24 BRIVIACT (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB. It was first approved in the EU and U.S. in 2016. Important safety information about BRIVIACT® is available below. BRIVIACT® (brivaracetam) CV U.S. Indication and Important Safety Information INDICATION IMPORTANT SAFETY INFORMATION
DOSING CONSIDERATIONS
IMPORTANT SAFETY INFORMATION 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 4 years to less than 16 years of age were generally similar to those in adult patients. BRIVIACT is a Schedule V controlled substance. Please refer to full Prescribing Information available at www.BRIVIACTHCP.com. Important Safety Information about BRIVIACT® in the EU and EEA BRIVIACT® (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Contraindications Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients. Special warnings and precautions for use Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including BRIVIACT®. Patients should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. Posology Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function. In adults with hepatic impairment, a 50 mg/day starting dose should be considered. In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended. A maximum daily dose of 150 mg administered in 2 divided doses is recommended for all stages of hepatic impairment. In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended. The maximum dose should not exceed 3 mg/kg/day. No clinical data are available in paediatric patients with hepatic impairment. BRIVIACT® film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take BRIVIACT®. Both the solution for injection/infusion and the oral solution contain sodium – to be taken into consideration for patients on a controlled sodium diet. The oral solution contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Interaction with other medicinal products and other forms of interaction With co-administration of BRIVIACT® 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was doubled. Intake of BRIVIACT® with alcohol is not recommended. In healthy subjects, co-administration with rifampicin, a strong enzyme-inducer (600 mg/day for 5 days), decreased BRIVIACT® area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of BRIVIACT® for patients starting or ending treatment with rifampicin. Other strong enzyme-inducers (such as St John´s wort [Hypericum perforatum]) may also decrease the systemic exposure of BRIVIACT®. Therefore, starting or ending treatment with St John’s wort should be done with caution. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g., lanzoprazole, omeprazole, diazepam). CYP2B6 induction has not been investigated in vivo and BRIVIACT® may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro studies have also shown that BRIVIACT® has inhibitory effects on OAT3. BRIVIACT® 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. BRIVIACT® plasma concentrations are decreased when co-administered with strong enzyme inducing antiepileptic drugs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Effects on ability to drive and use machines BRIVIACT®, has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of BRIVIACT®, on their ability to perform such activities. Undesirable effects The most frequently reported adverse reactions with BRIVIACT® (reported by >10% of patients) were somnolence (14.3%) and dizziness (11.0%). They were usually mild to moderate in intensity. Somnolence and fatigue (8.2 %) were reported at higher incidences with increasing dose. Other common adverse reactions (≥1% to <10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting and constipation. Neutropenia has been reported in 0.5% (6/1,099) BRIVIACT® - patients and 0% (0/459) placebo-treated patients. Four of these patients had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of BRIVIACT®. None of the six cases were severe, required any specific treatment, led to BRIVIACT® discontinuation or had associated infections. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT® -treated patients and 0.7 % (3/459) of placebo-treated patients. In short-term clinical studies of BRIVIACT® in patients with epilepsy, there were no cases of completed suicide and suicide attempt, however both were reported in the long-term open-label extension studies. In patients who were followed up in the open-label extension studies for up to 8 years, the safety profile was similar to that observed in the short-term, placebo-controlled studies. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of BRIVIACT® patients (9/3022) during clinical development. The safety profile of brivaracetam observed in children was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). There are limited safety data from open-label studies in children from 1 month to <4 years of age. Limited data are available on neurodevelopment in children <4 years of age. No clinical data are available in neonates. Overdose There is limited clinical experience with BRIVIACT® overdose in humans. Somnolence and dizziness were reported in a healthy subject taking a single dose of 1,400 mg of BRIVIACT®. There is no specific antidote. Treatment of an overdose should include general supportive measures. Since less than 10% of BRIVIACT® is excreted in urine, haemodialysis is not expected to significantly enhance BRIVIACT® clearance. Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 11 July 2018. http://www.ema.europa.eu/ For further information: Jim Baxter, Allyson Funk Investor Relations Neil Wallace, About UCB in Epilepsy: Forward looking statements 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. UCB is providing this information as of the date of this document 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. References: Open PDF of "UCB AES 2018 ENG"
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