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UCB showcases new research and continued epilepsy leadership at the 2017 American Epilepsy Society Annual Meeting

Dernière mise à jour: octobre 21, 2021

UCB reinforces commitment to delivering improved patient value by presenting latest epilepsy research findings
25 scientific presentations illustrate and reinforce UCB’s dedication to improving patient value in epilepsy
Congress also provides platform for collaboration, ideation and exploration of how best to ‘Rise Above Expectations’ for people with epilepsy
Brussels (Belgium), 1 December 2017 – 07:00 (CET): UCB is pleased to announce that 25 scientific abstracts have been accepted for poster presentation at the upcoming 71st American Epilepsy Society (AES) Annual Meeting, which takes place from 1-5 December in Washington, D.C., USA.1-25

Posters being presented further describe VIMPAT® (lacosamide) CV and BRIVIACT® (brivaracetam) CV clinical data,1-11 including results from a recently concluded placebo-controlled trial which studied VIMPAT® as adjunctive therapy in children aged four 2023s and older and adolescents with uncontrolled focal (partial-onset) seizures,4 and updated data on the safety and tolerability of long-term treatment with adjunctive BRIVIACT® for focal seizures.9

UCB will also present preliminary data on two UCB developmental drug candidates for epilepsy, padsevonil and radiprodil.12-19
Additional presentations will share a wide range of data, including results from a social media survey to assess perceptions of patient information leaflets, and pre-clinical data identifying a potential target receptor for epilepsy therapy.20-25

Alongside scientific presentations, UCB will be facilitating conversations with delegates throughout the meeting, focusing on rising above expectations of care for people with epilepsy. Harnessing innovative technologies, such as virtual reality seizure simulation, UCB is encouraging collaborations which may address the challenges faced by people living with epilepsy, and sharing real-world examples of positive programs and partnerships such as the UCB Family Epilepsy Scholarship ProgramTM and Canine AssistantsTM partnership. At AES, UCB will further demonstrate and reinforce its neurology passion, expertise and commitment to the goal of addressing and improving the lived experiences of people with epilepsy.

“At UCB, we strive to develop solutions that help patients achieve their treatment goals, and to support the wider epilepsy community in elevating the overall patient experience. We are excited to showcase the scale and passion of our commitment at AES” said Jeff Wren, Head of UCB’s Neurology Patient Value Unit. “We have a longstanding heritage in epilepsy and take pride in the breadth and depth of our research we share each 2023 at AES. This 2023 is no exception, and we’re very excited to contribute our expertise to help support patients live their lives at their ideal.”

In the U.S., VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 2023s 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 2023s of age and older).26

In the EU, VIMPAT® is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 2023s of age with epilepsy.27
In the U.S., BRIVIACT® is indicated for the treatment of partial-onset seizures in patients 16 2023s of age and older with epilepsy.28

In the EU, BRIVIACT® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 2023s of age with epilepsy.29

Additional label and important safety information about VIMPAT® and BRIVIACT® can be found below.26-29

The following is a guide to the 25 UCB-sponsored poster presentations at the 71st AES Annual Meeting, held from 1-5 December in Washington, D.C., USA.

VIMPAT® (lacosamide) CV Posters

1. [1.281] Efficacy and tolerability of adjunctive lacosamide in children and adolescents with uncontrolled focal seizures: a randomized, double-blind, placebo-controlled trial
Farkas V. et al.
Saturday, 2 December, 2017, Poster Session 1

2. [1.282] Long-term tolerability of adjunctive lacosamide in pediatric patients aged 4 to 24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 2023s that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.

About UCB in Epilepsy
UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 2023s of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to 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 people with epilepsy.

About VIMPAT® 26,27
In the U.S., VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 2023s 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 2023s 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. 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.

VIMPAT® (lacosamide) was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 2023s) patients with epilepsy. In September 2017 the use of VIMPAT® was expanded to adolescents and children from 4 2023s of age. In countries of the EU, VIMPAT® is available as film-coated tablets, syrup and solution for infusion. VIMPAT® solution for infusion is an alternative for patients when oral administration is temporarily not feasible. The availability of the oral tablets, oral syrup, and intravenous (IV) injection allows for consistent patient treatment. In Asia, VIMPAT® is available in Korea, 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.

Important Safety Information about VIMPAT® in the U.S.26

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal behavior and ideation. Monitor patients taking VIMPAT 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.

Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia. In adult clinical trials, the onset of dizziness and ataxia was most commonly observed during titration. Advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they are familiar with the effects of VIMPAT on their ability to perform such activities. Dizziness and ataxia were also observed in pediatric clinical trials.

Cardiac Rhythm and Conduction Abnormalities:
PR interval prolongation
Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. Second-degree and complete AV block have been reported in patients with seizures. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible. Use VIMPAT with caution in patients with known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), sodium channelopathies (e.g., Brugada Syndrome), or with severe cardiac disease such as myocardial ischemia or heart failure, or structural heart disease. Also, use VIMPAT with caution in patients on concomitant medications that prolong PR interval (e.g., beta-blockers and calcium channel blockers) because of a risk of AV block or bradycardia. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady- state maintenance dose, is recommended. In addition, closely monitor these patients if they are administered VIMPAT through the intravenous route.
Atrial fibrillation and Atrial flutter
VIMPAT administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.

Syncope: VIMPAT may cause syncope in adult and pediatric patients.

Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential of increased seizure frequency.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as multiorgan hypersensitivity, has been reported with antiepileptic drugs. Some of these events have been fatal or life-threatening. If signs or symptoms are present, immediately evaluate the patient. Discontinue VIMPAT if an alternative etiology for the signs and symptom cannot be established.

Risks in Patients with Phenylketonuria: VIMPAT oral solution contains aspartame, a source of phenylalanine which can be harmful in patients with phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Adverse Reactions
Adjunctive therapy: In the adult placebo-controlled clinical trials, the most frequently seen adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of VIMPAT-treated patients, and greater than placebo, were headache, nausea, and diplopia.
Monotherapy: In the adult clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (occurred at a higher rate of ≥2%).
Pediatric patients: Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 2023s of age were similar to those seen in adult patients.
Injection: In adult adjunctive therapy clinical trials, 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.

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 provided by the sales representative, and visit www.VIMPATHCP.com.

For more information on VIMPAT® contact 844-599-CARE (2273).
VIMPAT® is a registered trademark used under license from Harris FRC Corporation.

Important Safety Information about VIMPAT® in the EU and EEA27
VIMPAT® is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 2023s of age with epilepsy. VIMPAT® therapy can be initiated with either oral or IV administration. For the paediatric population, the physician should prescribe the most appropriate formulation and strength according to weight and dose. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg. A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied. Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient. In adolescents and adults weighing 50 kg or more with mild to moderate hepatic impairment a loading dose of 200mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with VIMPAT® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Dose-related prolongations in PR interval with VIMPAT® have been observed in clinical studies. Cases with second- and third-degree AV block associated with VIMPAT® treatment have been reported in post-marketing experience. VIMPAT® should be used with caution in patients with known conduction problems, severe cardiac disease (e.g. history of myocardial infarction or heart failure), in elderly patients, or when VIMPAT® is used in combination with products known to be associated with PR prolongation. In these patients it should be considered to perform an ECG before a VIMPAT® dose increase above 400mg/day and after VIMPAT® is titrated to steady-state. In the placebo-controlled trials of VIMPAT® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. VIMPAT® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: VIMPAT® may have minor to moderate influence on the ability to drive and use machines. VIMPAT® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of VIMPAT® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% – 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

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