Paediatric focal-onset seizures (FOS) account for around 60% of all epileptic seizures in children,1 which if uncontrolled can lead to life-long cognitive, emotional and physical consequences.



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UCB awaits decision from the European Commission (EC) on the potential approval of this new VIMPAT®  license extension in the European Union.
Brussels (Belgium), 24th July 2017 – 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 new license extension for its anti-epileptic drug (AED) VIMPAT® (lacosamide) for use as monotherapy and adjunctive therapy in the treatment of focal-onset seizures (FOS, also known as partial-onset seizures (POS) according to ILAE terminology2,3) in children from 4 to 16 years of age.4

The positive opinion is based on the principle of extrapolation of VIMPAT® efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children.

The European Commission’s (EC) approval decision is expected in the third quarter of 2017, which would further broaden the clinical application of VIMPAT®, and make a new treatment option available to aid the management of childhood epilepsy.
Epilepsy is the most common serious, neurological disorder among children and young adults, with the prevalence of paediatric epilepsy in Europe ranging from 3.2 – 5.1 per 1,0005.  Childhood epilepsy is a chronic condition and paediatric focal seizure prevalence increases with age.6,7,8,9  Repeated seizures in childhood may result in important neuro-development delay as well as direct physical injury. Approximately 10 – 29% of paediatric patients have inadequate seizure control with currently available AEDs.10,11  Paediatric patients may suffer from adverse events with currently available AEDs.12  As such, there is a need for additional treatment options that may provide seizure control with a low side effect profile.

“The management of paediatric epilepsy is challenging and poor seizure control can be a great burden of stress for children and their families,” said Jeff Wren, Head of UCB’s Neurology Patient Value Unit. “UCB is proud to play a part in improving the lives of children with epilepsy and we look forward to making this therapy available to this patient population in the EU, pending EC approval.”

The established efficacy, safety and tolerability of adjunctive VIMPAT® therapy in adults with focal seizures was previously demonstrated by three primary double-blind, placebo-controlled studies (SP0667, SP0754, and SP0755)13,14,15 and three open-label extension studies (SP0615, SP0756, and SP0774).16,17,18  The efficacy, safety and tolerability profile of first-line VIMPAT® monotherapy has been demonstrated in a phase 3, double-blind, active comparator trial (SP0993) and the related open-label extension study (SP0994).19  VIMPAT® has over 1,056,500 patient-years of exposure.20  

“Non-adherence to AEDs is a common problem for children with epilepsy, in particular those with newly diagnosed epilepsy. Non-adherence is a potentially remediable cause of poor seizure control; continued seizures can be devastating and lead to long-term physical, behavioural and psychological consequences for children,” said Professor Helen Cross, Honorary Consultant in Paediatric Neurology at UCL Institute of Child Health. “There are currently few AEDs which are licensed for the treatment of younger children with focal onset seizures, especially as monotherapy. As such, the availability of lacosamide would provide an additional treatment option to support healthcare professionals in the management of childhood epilepsy.”

The EMA has established that focal epilepsies in children of 4 years of age have a similar clinical expression to focal epilepsies in adolescents and adults.21  The Food and Drug Administration (FDA) and EMA allow extension of indication to paediatric populations using extrapolated data provided the dose is established and the safety is demonstrated. The EMA states that, from the safety viewpoint, a minimum of 100 children treated by the study drug should be followed for at least one year.22 The Paediatric Epilepsy Academic Consortium for Extrapolation (PEACE) has shown that AED concentrations at approved doses lead to similarity of exposure between adult and paediatric patients.22,23

Currently VIMPAT® is approved in 72 countries worldwide. In the EU it is approved as monotherapy and adjunctive therapy for the treatment of POS with or without secondary generalisation in adults and adolescents (16-18 years) with epilepsy24.  In the US, VIMPAT® is approved as monotherapy or adjunctive therapy for the treatment of POS in adults with epilepsy (ages ≥ 17 years).25  

About VIMPAT®
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 years) patients with epilepsy. 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. VIMPAT® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. VIMPAT® injection is a short-term replacement when oral administration is not feasible in these patients.
VIMPAT® oral solution was launched in the US in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. In Asia, VIMPAT® is available in Korea, Hong Kong, Malaysia, Philippines and Thailand, and was recently approved for use in Japan, where the product will be jointly commercialised by Daiichi Sankyo. VIMPAT® is not approved in China. Important safety information about VIMPAT® is available below.

About Epilepsy26,27
Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years 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 years 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 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 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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