VIMPAT® is approved for monotherapy and adjunctive therapy of partial-onset (focal) seizures in children aged 4 years and older and now provides a new treatment choice for physicians and their paediatric patients with epilepsy.1



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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 1,000.2
Despite its high prevalence, approximately 10 – 29% of paediatric epilepsy patients experience inadequate seizure control with currently available anti-epileptic drugs.3,4
Brussels (Belgium), 21 September 2017 – 18:00 (CEST): UCB today announced that the European Commission (EC) approved expanding the use of its anti-epileptic drug (AED) VIMPAT® (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (also known as focal-onset seizures (FOS) according to ILAE terminology 5,6) with or without secondary generalisation in adults, adolescents and children from 4 years of age.1

The approval follows a positive opinion adopted in July by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and provides a new treatment option to aid the management of childhood epilepsy.7

“Today’s approval of VIMPAT® for children aged 4 to 16 is an important step forward for the management of paediatric epilepsy, a condition which can present significant challenges to children and their families,” said Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “One of our key commitments at UCB is to improve the lives of people with epilepsy, and we are proud to be providing a proven treatment option for this highly impacted patient population.”

Epilepsy is a common, chronic neurological disorder, affecting approximately 65 million people worldwide,8 with almost half of incident cases diagnosed during childhood.9 There are a number of comorbidities in childhood that may be associated with epilepsy, including cognitive impairment and neuropsychiatric conditions, mood disorders, and physical comorbidities.10 The stigma associated with epilepsy, especially during adolescence, has been related to low self-esteem, worry, and negative feelings about life,11 with 12 – 26% of children with epilepsy reporting depression and anxiety.12  Paediatric patients may suffer from adverse events with currently available AEDs.13 As such, there is a need for additional treatment options that may provide seizure control with a low side effect profile.

“Paediatric patients with focal seizures can still experience poor seizure control with currently available treatment options, along with a reduced quality of life,” said Professor Alexis  Arzimanoglou,  Coordinator of the Epilepsy Program of the Epilepsy Unit at San Juan de Deu Barcelona Children's University Hospital and Director of the Paediatric Clinical Epileptology, Sleep disorders and Functional Neurology Department at the University Hospitals of Lyon, France.  “With the approval of lacosamide, healthcare professionals and paediatric patients in the EU now have an additional treatment option for focal onset seizures, either as monotherapy or adjunctive therapy, representing a great advance to further help children aged 4 years and older suffering from epilepsy.”

The approval of VIMPAT is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. The EMA has established that focal epilepsies in children older than 4 years old have a similar clinical expression to that in adolescents and adults.14 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.14

VIMPAT has over 1,056,500 patient-years of exposure.15 Its established efficacy, safety and tolerability of adjunctive therapy in adults with focal seizures has been demonstrated by three double-blind and three open-label extension studies.16,17,18,19,20,21 The efficacy, safety and tolerability profile of first-line VIMPAT monotherapy has been demonstrated in a phase 3, double-blind study and a related open-label extension study.22

VIMPAT is approved in 72 countries worldwide. In the EU, it is also approved as monotherapy and adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondary generalisation in adults and adolescents (16 – 18 years) with epilepsy.23 In the US, VIMPAT is approved as monotherapy or adjunctive therapy for the treatment of POS in adults with epilepsy (ages ≥ 17 years).24

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 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.

About Epilepsy 8,25

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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