UCB sponsors several data presentations on epilepsy, including new real-life data on Vimpat® at the 10th European Congress on Epileptology
Brussels (Belgium), 24th September, 0700 CEST – UCB today announced that data involving UCB’s marketed anti-epileptic drugs (AEDs), Vimpat®(lacosamide) and Keppra® (levetiracetam), and its investigational medicine for epilepsy, brivaracetam, will be presented at the 10th European Congress on Epileptology (ECE) in London from September 30th – October 4th. A UCB sponsored analysis examining health-related quality of life of patients in the PatientsLikeMe™ epilepsy community will also be presented at the congress.
“At UCB, we have a strong heritage in epilepsy as well as a promising pipeline. The information to be presented at this year’s ECE share data across UCB’s broad epilepsy portfolio and demonstrate our continued commitment to research and improving the lives of people living with this disease,” said Dr. Barbara Schäuble, Senior Director, Global Medical Affairs, UCB, “In particular, the breadth of data on Vimpat® provides important insight for healthcare professionals into its use in daily clinical practice.”
Vimpat® is indicated as an add-on therapy for the treatment of partial-onset seizures in adults with epilepsy.1,2 The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat® in the European Union and the US is available at the end of the press release.
Keppra® (levetiracetam) is a broad spectrum AED indicated for a number of different seizure types.3,4,5 Please see below for full indication and important safety information for the European Union and the US.
Brivaracetam is an investigational medicine currently in phase III development for the adjunctive treatment of partial onset seizures.
UCB is a leading biopharmaceutical company committed to developing innovative therapies and delivering meaningful support programs to improve the lives of people living with epilepsy. In addition to the sponsored data presentations detailed below and building on the relevance of clinical experience and real world data insights, UCB is also sponsoring a satellite symposium at the ECE, on October 2nd (1630-1800) entitled ‘Managing Epilepsy: Learning from Today to Inform Tomorrow’.
The following is a guide to UCB-sponsored data to be presented at ECE.
UCB-Sponsored Presentations at the 10th ECE
Vimpat® (lacosamide) presentations:
1. A Retrospective Observational Study of Comparative Lacosamide Cost in a Real World Setting in the USA (VOYCE)
Poster session: Tuesday, October 2, 12.30PM – 2.00PM
2. Long-Term Treatment With Adjunctive Lacosamide for Partial-Onset Seizures: An Analysis of Results From Patients Exposed Only to Approved Doses
Platform session – Antiepileptic drugs: Monday, October 1, 11.30AM – 12.30PM
3. Exposure-Response Modeling Of Lacosamide In Adjunctive Treatment Of Patients With Partial-Onset Seizures
Poster session: Monday, October 1, 12.30PM – 2.00PM
4. Lacosamide as Add-on to Monotherapy in Patients With Partial-Onset Seizures: Interim Results of the Post-Marketing VITOBA Study (VImpaT added to One Baseline AED)
Poster session: Wednesday, October 3, 12.30PM – 2.00PM
5. Drug Utilization Study With Lacosamide in Daily Clinical Practice in Belgium: an Interim Analysis
Poster session: Tuesday, October 2, 12.30PM – 2.00PM
Keppra® (levetiracetam) and brivaracetam presentations:
1. Meta-Analysis of Nonpsychotic Behavioral Treatment Emergent Adverse Events in Brivaracetam and Levetiracetam Development Programs
Poster session: Tuesday, October 2, 12.30PM – 2.00PM
Epilepsy presentation:
1. Health-Related Quality of Life of Patients in the PatientsLikeMe Epilepsy Community
Poster session: Monday, October 1, 12.30PM – 2.00PM
About Vimpat®
Vimpat® (film-coated tablets, syrup and solution for infusion) was launched in the European Union in 2008 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® solution for infusion may be used when oral administration is temporarily not feasible. Vimpat® syrup (10mg/ml) was approved for use in the European Union in 2012.
The maximum recommended daily dose for Vimpat® in the European Union and the U.S. is 400 mg/day.
Vimpat® tablets and injection were launched in the US in May 2009 as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. Vimpat® injection is a short-term replacement when oral administration is temporarily not feasible. Vimpat® oral solution was launched in June 2010.
The availability of the oral tablets, oral solution, and IV injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat® -treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat® is available at the end of the press release.
Important safety information about Vimpat® in the EU and EEA
Vimpat® (lacosamide) 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® solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 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. Second degree or higher AV block has been reported in post-marketing experience. 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 counselled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Vimpat® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).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. 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 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. Potential cases have been reported rarely with Vimpat® and if multiorgan hypersensitivity reaction is suspected, Vimpat® should be discontinued. 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. 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, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. 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.
Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 19th March 2012.
http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed 24th July 2012)
Important safety information about Vimpat® C-V in the U.S.
Warnings and Precautions
Antiepileptic drugs (AEDs), including Vimpat®, increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider.
Patients should be advised that Vimpat® may cause dizziness and ataxia. Therefore patients should not drive a car or operate complex machinery until they are familiar with the effects of Vimpat® on their ability to perform such activities.
Dose-dependent PR interval prolongation has been observed in Vimpat® clinical studies in patients and in healthy volunteers. When Vimpat® is given with other drugs that prolong the PR interval, further PR prolongation is possible. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting) and told to contact their physician should any of these occur. Vimpat® should be used with caution in patients with known cardiac conduction problems or with severe cardiac disease. In such patients, obtaining an ECG before beginning Vimpat®, and after Vimpat® is titrated to steady state, is recommended.
Vimpat® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid pulse, shortness of breath) and told to contact their physician should these symptoms occur.
Patients should be advised that Vimpat® may cause syncope.
Vimpat® should be gradually withdrawn (over a minimum of 1 week) to minimize the potential of increased seizure frequency.
Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, Vimpat® should be discontinued.
Vimpat® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.
Common Adverse Reactions
In 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.
Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended. Dose titration should be performed with caution in all renally impaired patients.
In clinical trials, adverse reactions with intravenous administration generally appeared similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).
For full prescribing information on Vimpat®, visit http://www.vimpat.com/prescribing-information.aspx (Accessed 5th March, 2012).
For more information on Vimpat®, visit www.Vimpat.com or contact UCB at (800) 477-7877.
Vimpat® (C-V) is a Schedule V controlled substance.
Vimpat® is a registered trademark used under license from Harris FRC Corporation.
About Keppra®
In the European Union, Keppra® (formulations) is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Keppra® is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy. Keppra® is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. Keppra® is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy. Keppra® concentrate for solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
In the U.S. Keppra® tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children one month of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Keppra® injection is an antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:
• Partial onset seizures
• Myoclonic seizures in patients with Juvenile Myoclonic Epilepsy
• Primary generalized tonic-clonic seizures
Keppra® in the European Union – Important Safety Information
Contraindication: Keppra® is contraindicated in patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients. Special warnings and precautions for use: In accordance with clinical practice if Keppra® has to be discontinued it is recommended to withdraw it gradually. The administration of Keppra® to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection. Suicide, suicide attempt and suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents (including levetiracetam). Patients should be monitored for signs or depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. The tablet formulation is not adapted for use in infants and children under the age of 6 years. Undesirable effects: The adverse event profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The safety profile of levetiracetam is generally similar across age groups (adults and paediatric patients) and across the approved epilepsy indications.
Adverse reactions (very common and common) reported in clinical studies (adults, adolescents, and children and infants >1 month) and from post-marketing experience are listed below. Very common undesirable effects (frequency ≥1/10): nervous system disorders – somnolence and headache; infections and infestations - nasopharyngitis. Common undesirable effects (frequency ≥1/100, <1/10): General disorders and administration site conditions - asthenia/fatigue; Nervous system disorders - convulsion, dizziness, tremor, balance disorder, lethargy; Psychiatric disorders - depression, hostility/aggression, insomnia, nervousness/irritability, anxiety; Gastrointestinal disorders - abdominal pain, diarrhoea, dyspepsia, nausea, vomiting; Metabolism and nutrition disorders - anorexia. The risk of anorexia is higher when topiramate is co-administered with levetiracetam; Ear and labyrinth disorders - vertigo; Respiratory, thoracic and mediastinal disorders - cough; Skin and subcutaneous tissue disorders - rash.
Interaction with other medicinal products and other forms of interaction: Pre-marketing data from clinical studies conducted in adults indicate that Keppra® did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of Keppra®.
Please refer to the European summary of product characteristics for other adverse reactions and full prescribing and safety information. Date of last revision 25th May 2012 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000277/WC500041334.pdf (Accessed June 2012)
Keppra® in the U.S. - Important Safety Information
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Keppra® is also associated with the occurrence of central nervous system adverse events including somnolence and fatigue and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation and other abnormalities). Keppra® should be gradually withdrawn to minimize the potential of increased seizure frequency. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, asthenia, infection and dizziness. In pediatric patients, the most common adverse events associated with Keppra® in combination with other AEDs were fatigue, aggression, nasal congestion, decreased appetite, and irritability. The adverse reactions for patients with JME and PGTC seizures are expected to be essentially the same as for patients with partial seizures. The adverse reactions for Keppra® injection include all of those associated with Keppra® tablets and oral solution. US prescribing information is available at
http://www.ucb.com/_up/ucb_com_products/documents/Keppra_Labeling_12_2011.pdf (Accessed July 2012)
http://www.ucb.com/_up/ucb_com_products/documents/Keppra_%20Injection_COL_%208E_%2006_2011.pdf (Accessed July 2012)
References
1. http://www.vimpat.com/prescribing-information.aspx (Accessed 5th July, 2012).
2. http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed 5th July, 2012)
3. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000277/WC500041334.pdf (Accessed 5th July, 2012)
4.http://www.ucb.com/_up/ucb_com_products/documents/Keppra_Labeling_12_2011.pdf
5. http://www.ucb.com/_up/ucb_com_products/documents/Keppra_%20Injection_COL_%208E_%2006_2011.pdf
For further information
Eimear O Brien, Director, Brand Communications, UCB T +32.2.559.9271, eimear.obrien@ucb.com
Andrea Levin, Senior PR Manager, US Communications and Public Relations, UCB
T +1 770 970 8352, andrea.levin@ucb.com
Antje Witte, Investor Relations, UCB
T +32.2.559.9414, antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com
About the Excellence in Epilepsy Journalism Award
The 2012 Excellence in Epilepsy Journalism Award is open to all journalists and aims to raise awareness about epilepsy across the globe. The award is a joint initiative of the International Bureau for Epilepsy and UCB and recognises journalists who have excelled in reporting on this often-misunderstood condition.
If you would like to find out more information, please visit: http://www.ibe-epilepsy.org/activities/excellence-in-journalism-award-2012
About UCB
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 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statements
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LCM-PRR-014788-072012
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