- Trial further highlights UCB’s longstanding commitment to enhancing value for people living with epilepsy
- Data submitted to EMA earlier this year to extend the marketing authorization for lacosamide to include monotherapy. In the Europe, lacosamide is currently only approved as adjunctive therapy.
New clinical trial data, presented at the second Congress of the European Academy of Neurology (EAN), showed non-inferiority of lacosamide (VIMPAT®) monotherapy compared with controlled-release carbamazepine among patients with newly or recently diagnosed focal epilepsy.
The results are from a Phase III international, double-blind, randomized, active-controlled trial, the fourth in a series of non-inferiority trials conducted according to guidance issued by the European Medicines Agency and the International League Against Epilepsy.
Overall, 888 patients aged 16 years or older took part in the study, making it the largest trial of its kind so far. The proportion of patients completing six months of treatment without experiencing a seizure was 75.2% with lacosamide (200–600mg/day) and 71.8% with carbamazepine-CR (400–1200mg/day) per protocol population. This corresponded to 91.5% and 92.8% respectively, based on Kaplan Meier-predicted six month seizure freedom rates, the primary assessment for this trial. The adverse event (AE) profile was comparable to that observed in previous lacosamide trials, including dizziness, headache, fatigue, somnolence and nausea.1,2
“Selection of the first antiepileptic drug is one of the most important decisions for patients with newly diagnosed disease – together, we need to choose one that is effective, has good tolerability, low potential for drug-drug interactions, and suits their profile and co-morbidities, so that they can take it for a long time”, explained Professor Michel Baulac, Hôpital de la Pitié-Salpêtrière, Paris, France. “Epilepsy is a complex, multifactorial disease and not all patients will respond to currently available options; consequently, addition of another antiepileptic drug to the selection we can choose from when seeing patients for the first time, is very welcome news”.
Earlier this year, UCB submitted the data to the European Medicines Agency to extend the marketing authorization of lacosamide to include monotherapy, further supporting the efficacy and safety of this treatment and reinforcing UCB’s belief in the potential for this indication.
“VIMPAT® is already available as monotherapy in the United States and we hope it will soon reach patients in the EU. UCB is committed to making this product available to many more people living with epilepsy worldwide, regardless of the stage of their disease, whether newly diagnosed, or refractory”, said Jeff Wren, Patient Value Head Neurology and Executive Vice President UCB. “In recent years, VIMPAT® has helped many patients requiring adjunctive therapy for focal epilepsy. Results of this trial suggests that it may provide similar benefits as first-line monotherapy, building on our longstanding commitment to enhance value for people with seizure disorders at every point of their journey.”
Lacosamide (trade name VIMPAT®) is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages ≥ 17 years in the U.S., ages ≥ 16 years in the EU) and in the U.S. also as monotherapy. In the EU, lacosamide is not currently approved for use as monotherapy. Important safety information for lacosamide is available below.2,3
About VIMPAT®
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. 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 U.S. 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 Korea, Hong Kong, Malaysia, Philippines and Thailand. VIMPAT® is not approved in Japan and China. Important safety information about VIMPAT® is available below.
About Epilepsy4,5
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 rich heritage in epilepsy with over 20 years of experience in the research and development of novel antiepileptic drugs. Every day, thousands of people use AEDs from our portfolio to help control their seizures. As a company with a long-term commitment to epilepsy research our goal is to address unmet medical needs and to deliver solutions that improve patients’ lives. 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.
France Nivelle
Global Communications, UCB
T +32.2.559.9178
france.nivelle@ucb.com Jim Baxter,
Neurology Communications, UCB
T+32.2.473.78.85.01
jim.baxter@ucb.com
Investor Relations
Antje Witte
Investor Relations, UCB
T +32.2.559.94.14
antje.witte@ucb.com Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588,
isabelle.ghellynck@ucb.com
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 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014.
