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UCB’s anti-epileptic drug VIMPAT[®] (lacosamide) receives EU CHMP positive opinion for primary generalised tonic-clonic seizures

· Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a licence extension for its anti-epileptic drugs VIMPAT (lacosamide) and Lacosamide UCB (lacosamide) as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy[1 ](IGE)
· IGEs (idiopathic generalised epilepsy) account for 20%–40% of all epilepsies[2], characterized by different generalized seizure types (absence, myoclonic and PGTCS)[3] 
· Patients living with generalized tonic-clonic seizures have an increased risk of injury[4] and those who experienced three or more in one year had a fifteen-fold increased risk of sudden unexpected death in epilepsy[5]
· UCB awaits decision from the European Commission (EC) on the potential approval of this new VIMPAT[®]  license extension in the European Union 

Brussels (Belgium), 22 October 2020, 07:00 (CEST): UCB today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a licence extension for its anti-epileptic drugs VIMPAT® (lacosamide) and Lacosamide UCB (lacosamide) as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

The positive opinion is based, in part, on results from a phase 3 study of lacosamide as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), recently published in the Journal of Neurology, Neurosurgery & Psychiatry.6 

In the study, UCB’s anti-epileptic Drug (AED) lowered the risk of developing a second primary generalized tonic-clonic seizure during a 24-week period and demonstrated a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo. Lacosamide was generally tolerated by patients enrolled in the study. 

Idiopathic generalized epilepsy, (IGEs) account for 20%–40% of all epilepsies2 and are characterized by different generalized seizure types (absence, myoclonic and PGTCS).3 Patients living with generalized tonic-clonic seizures have an increased risk of injury4 and those who experienced three or more in one year had a fifteen-fold increased risk of sudden unexpected death in epilepsy.5

People living with uncontrolled primary generalized tonic-clonic seizures face tremendous challenges and currently have few treatment options available to them. This form of epilepsy can be devastating, significantly impacting the quality of a patient’s life. Additionally, many patients are refractory, meaning they do not respond to currently approved medicines. This unpredictability can present numerous challenges and barriers”, explained Iris Loew-Friedrich, Executive Vice President and Chief Medical Officer, UCB. “We are very pleased the CHMP has recognised the impact of PGTCS, and the importance of broadening the number of adjunctive therapies available to people living with this type of epilepsy”.

The European Commission’s (EC) formal approval decision is expected before the end of 2020, which would further broaden the clinical application of VIMPAT® and make a new treatment option available to aid the management of PGTCS. 
 
UCB remains committed to strengthening our leadership in epilepsy and to investigating new approaches and innovative solutions to deliver improved outcomes and experiences to the global epilepsy community. This applies equally to our current expansive in-market epilepsy portfolio as well as to our exciting pipeline. We know that people living with PGTCS currently have limited treatment options. With today’s CHMP positive opinion we’re excited that we’re one step closer to having an approved medicine to support the European epilepsy community,” explained Charl van Zyl, Executive Vice President & Head of Neurology Solutions, UCB.

VIMPAT® is currently not approved for PGTCS in any country in the world. In addition to this CHMP positive opinion, regulatory reviews for use of VIMPAT as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy four years of age and older compared to placebo are underway in the U.S., Japan, and Australia.

About Epilepsy
Epilepsy is the main symptom of a variety of chronic disorders of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people.7 Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.8

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 30 years of experience in the research and development of anti-epileptic 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 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 7,600 people in approximately 40 countries, the company generated revenue of € 4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news 

About VIMPAT®  in the EU 
VIMPAT® was first launched in the European Union in September 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. 

In countries of the EU, VIMPAT® is available as film-coated tablets, syrup and solution for infusion. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible.   

Important Safety Information about VIMPAT® in the EU and EEA9  
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 years 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 serious cardiac arrhythmia and 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. Administration of a loading dose has not been studied in children. A maximum dose of 300 mg/day is recommended for paediatric patients with mild to moderate hepatic impairment weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment as well.  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.  VIMPAT® should be used with caution in patients with underlying proarrhythmic conditions such as patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and sodium channel blocking antiepileptic medicinal products, as well as in elderly patients. 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. In post-marketing experience, AV block (including second degree or higher AV block) has been reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions. Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to seek immediate medical advice if 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). Vimpat Syrup contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Vimpat syrup contains propylene glycol (E1520). VIMPAT® syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. VIMPAT® solution for infusion contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 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, 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. The safety profile of lacosamide in placebo-controlled and in open-label studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %). 
Laboratory abnormalities: Abnormalities in liver function tests have been observed in placebo-controlled trials with VIMPAT® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic medicinal products. 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 medicinal products. 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: 03 Sept 2019. http://www.ema.europa.eu/ 

References
  

  1. https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ws/1782_en.pdf  Date Accessed 20 October
  2. Marini C., King M.A., Archer J.S., Newton M.R., Berkovic S.F. Idiopathic generalised epilepsy of adult onset: clinical syndromes and genetics. J Neurol Neurosurg Psychiatry 2003; 74(2):192–6
  3. Benbadis SF. Practical management issues for idiopathic generalised epilepsies. Epilepsia. 2005;46(Suppl 9):125-132. 
  4. Asadi-Pooya AA, Nikseresht A, Yaghoubi E, et al. Physical injuries in patients with epilepsy and their associated risk factors. Seizure 2012;21:165–8.
  5. DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpected death in epilepsy. Front Neurol. 2017;8:473
  6. Vossler DG, et al. Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomized, placebo-controlled trial. Neurol Neurosurg Psychiatry 2020; 91(10):1067-1075
  7. Epilepsy Foundation. Who gets epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy  https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Date Accessed 20 October 2020
  8. International League Against Epilepsy. Definition of Epilepsy 2014.  https://www.ilae.org/guidelines/definition-and-classification/definition-of-epilepsy-2014 Date Accessed 19 October 2020
  9. Vimpat (lacosamide) EU Summary of Product Characteristics https://www.ema.europa.eu/en Date Accessed 20 October



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