· 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 I October 22, 2020 I 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.
References
- https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ws/1782_en.pdf Date Accessed 20 October
- 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
- Benbadis SF. Practical management issues for idiopathic generalised epilepsies. Epilepsia. 2005;46(Suppl 9):125-132.
- 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.
- DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpected death in epilepsy. Front Neurol. 2017;8:473
- 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
- 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
- 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
- Vimpat (lacosamide) EU Summary of Product Characteristics https://www.ema.europa.eu/en Date Accessed 20 October
SOURCE: UCB
