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BRUSSELS, Dec. 2, 2016 /PRNewswire/ -- UCB is pleased to announce that 12 scientific abstracts have been accepted for poster presentation at the upcoming 70th American Epilepsy Society (AES) Annual Meeting, which takes place from 2-6 December in Houston, TX, USA.1-12
Data being presented include posters further describing the safety and efficacy profile of VIMPAT® (lacosamide) CV and BRIVIACT® (brivaracetam) CV.2,3,4,6,8 Presentations will also share findings on the current state of the union of epilepsy care and antiepileptic drugs in the U.S. and a database analysis of treatment gaps in newly diagnosed patients with epilepsy in the United States (U.S.)11,12 Additionally, data on the long-term healthcare costs associated with enzyme-inducing antiepileptic drugs vs. non-enzyme-active antiepileptic drugs in the United Kingdom (U.K.) will be presented and discussed at the meeting.10
In the U.S., VIMPAT® is approved as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 17 years and older.13 BRIVIACT® is approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.14 European label information can be found below.15,16
"At UCB, we strive to bring value to patients. Therefore, we are excited to share findings at AES," said Jeff Wren, Head of UCB's Neurology Patient Value Unit. "We take pride in our longstanding commitment to bringing new scientific advances to the epilepsy community and are pleased to continue our tradition of unveiling new research at AES."
The following is a guide to the 12 UCB-sponsored poster presentations at the 70th AES Annual Meeting, held 2-6 December in Houston, Texas, USA.
VIMPAT® (lacosamide) CV Posters (6 in total)
1. [2.369] Pregnancy outcomes following exposure to lacosamide – results from a global
safety database Golembesky A. et al. Sunday 4 December, 2016, Poster Session 2
2. [1.268] Randomized double-blind non-inferiority trial of lacosamide versus controlled-
release carbamazepine monotherapy – subgroup analysis of unclassified patients with
initial generalized tonic-clonic seizures only Werhahn K. et al. Saturday 3 December, 2016, Poster Session 1
3. [1.267] Efficacy and Tolerability of Lacosamide Monotherapy in Elderly Patients with
Newly Diagnosed Epilepsy: Subgroup Analysis of a Non-Inferiority Trial Versus
Controlled-Release Carbamazepine Rosenow F. et al. Saturday 3 December, 2016, Poster Session 1
4. [1.285] Tolerability and effectiveness of lacosamide monotherapy in patients with
newly diagnosed epilepsy and psychiatric comorbidities: Post-hoc analysis of a
prospective randomized double-blind trial Schmitz B. et al. Saturday 3 December, 2016, Poster Session 1
5. [1.284] Lacosamide plasma concentration and tolerability during add-on compared to
monotherapy by CYP class of the background AED: Post-hoc analysis of a conversion to
lacosamide monotherapy trial Dimova S. et al. Saturday 3 December, 2016, Poster Session 1
6. [1.269] Long-term safety and tolerability of adjunctive lacosamide in children with focal
epilepsy: Interim results from an open-label trial Ferreira J.E. et al. Saturday 3 December, 2016, Poster Session 1
BRIVIACT® (brivaracetam) CV Posters (3 in total)
7. [2.207] The effect of brivaracetam on the pharmacokinetics of phenytoin: in vivo, in
vitro, and modeling studies Moseley BD. et al. Sunday 4 December, 2016, Poster Session 2
8. [3.234] Safety and tolerability of intravenous brivaracetam: pooled data from healthy
volunteers and adults with epilepsyKlein P. et al. Monday 5 December, 2016, Poster Session 3
9. [2.267] Testing a new QOLIE-31-P total score algorithm using data from brivaracetam
Phase III studies Cramer J. et al. Sunday 4 December, 2016, Poster Session 2
Epilepsy posters (3 in total)
10. [1.286] Comparing long-term healthcare costs associated with the use of enzyme-
inducing antiepileptic drugs (EIAEDs) and non-enzyme-active antiepileptic drugs
(nEAAEDs) in elderly patients Thieffry S. et al. Saturday 3 December, 2016, Poster Session 1
11. [2.199] A US database analysis of treatment gaps in newly diagnosed patients with
epilepsy Kalilani L. et al. Sunday 4 December, 2016, Poster Session 2
12. [1.282] Current State of the Union of Epilepsy Care in the United States: Antiepileptic
Drugs Sirven J. et al. Saturday 3 December, 2016, Poster Session 1
Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., more than 2 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. One third of patients with epilepsy live with uncontrolled seizures.
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.
About VIMPAT® 13,15
VIMPAT® is approved in the U.S. as film-coated tablets, injection for intravenous use and oral solution, as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy ages 17 years and older. VIMPAT® injection is indicated as short-term replacement when oral administration is not feasible in these patients.13
A single loading dose administration option is also approved in the U.S. for all formulations of VIMPAT® when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
In the European Union, VIMPAT® (film-coated tablets, syrup and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT® is also approved in the European Union for initiation as a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice-daily maintenance dose regimen.15
Within Asia, VIMPAT® is available in Japan, Korea, Hong Kong, Malaysia, Philippines and Thailand.
Important Safety Information about VIMPAT® in the U.S.13
Warnings and Precautions
The loading dose should be administered with medical supervision considering the VIMPAT® pharmacokinetics and increased incidence of CNS adverse reactions. 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. Dose titration should be performed 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 at http://www.vimpat.com/pdf/vimpat_PI.pdf.
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 EEA15
VIMPAT® is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT® therapy can be initiated with either oral or IV administration. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of VIMPAT® 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. 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. 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 or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when VIMPAT® is used in combination with products known to be associated with PR prolongation. 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 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 counselled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents 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. 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 VIMPAT®), 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%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration, contusion. The use of VIMPAT® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with VIMPAT® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of VIMPAT® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is suspected, VIMPAT® should be discontinued.
Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 30 July 2015 http://www.ema.europa.eu/
BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).14,16
Important Safety Information about BRIVIACT® in the U.S.14
Warnings and Precautions
The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf.
For more information on BRIVIACT®, contact 844-599-CARE (2273).
BRIVIACT® is a registered trademark of the UCB Group of Companies.
Important Safety Information about BRIVIACT® in the EU and EEA16
BRIVIACT® (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 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. Dose adjustments are recommended for patients with hepatic impairment (50 mg/day starting dose should be considered, up to maximum daily dose of 150 mg administered in 2 divided doses). 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 interaction studies have shown that BRIVIACT® can inhibit CYP2C19, therefore BRIVIACT® 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. 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: 10 March 2016. http://www.ema.europa.eu/
For further information:
France Nivelle, Global Communications, UCB
Antje Witte, Investor Relations, UCB
Jim Baxter, Neurology Communications, UCB
Isabelle Ghellynck, Investor Relations, UCB
Laurent Schots, Media Relations, UCB
1-12. AES Congress posters, presentation details above. Scientific programme available online: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/find/2.199/3/0/0 date accessed 30th November 2016.
13. Vimpat® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.vimpat.com/pdf/vimpat_PI.pdf date accessed 30th November 2016
14. Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. https://www.briviact.com/briviact-PI.pdf date accessed 30th November 2016.
15. Vimpat® EU Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf date accessed 30th November 2016.
16. Briviact® EU Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003898/WC500200206.pdf date accessed 30th November 2016.
17. The Epilepsy Foundation of America. Who Gets Epilepsy http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 30th November 2016.
18. The Epilepsy Foundation of America. What is Epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy. Accessed 30th November 2016.
UCB, Brussels, Belgium (www.ucb.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 7700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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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.
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