Vimpat (lacosamide) Now Approved by FDA for Primary Generalized Tonic-Clonic Seizures and Expanded Pediatric Use for People Living with Epilepsy
ATLANTA, Nov. 17, 2020 /PRNewswire/ -- UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Vimpat (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and Vimpat injection for intravenous use in children four years of age and older.1 PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.2
"These approvals underscore UCB's commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community," said Mike Davis, Head of U.S. Neurology at UCB. "We are pleased that Vimpat is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control."
The PGTCS approval is based, in part, on results of a Phase 3 study recently published in the Journal of Neurology, Neurosurgery & Psychiatry.3 Adjunctive treatment with VIMPAT resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% (p=0.001), and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, p=0.011).
People 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
"The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy," said David Vossler, MD, FAAN FACNS FAES, Department of Neurology, University of Washington, Seattle, USA. "Bolstered by a wealth of data demonstrating the efficacy and safety of Vimpat, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced."
Results from the Phase 3 study showed that Vimpat was generally tolerated in patients with Idiopathic Generalized Epilepsy (IGE) and PGTCS. The most common adverse reactions (≥10%) reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.
Regarding the expanded pediatric population, Vimpat tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. Vimpat injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older).
In October 2020, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy.6 Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in Japan and Australia.
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. 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.7
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 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.
UCB, Brussels, Belgium (www.ucb-usa.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 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: @UCBUSA.
About Vimpat (lacosamide)
Vimpat was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. Vimpat was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. Vimpat is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.
Vimpat is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Vimpat is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Forward looking statements – UCB
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- 1. VIMPAT® (lacosamide) CV. U.S. Prescribing Information
- 2. NIHR: National Institute for Health Research. Lacosamide for primary generalised tonic-clonic seizures – adjunctive therapy. http://www.io.nihr.ac.uk/wp-content/uploads/2019/07/27110-Lacosamide-for-Primary-Generalized-Tonic-Clonic-Seizures-V1.0-JULY2019-NON-CONF.pdf
- 3. 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
- 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
- 5. DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpected death in epilepsy. Front Neurol. 2017;8:473
- 6. European Medicine Agency: Committee for Medicinal Products for Human Use (CHMP). https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ws/1782_en.pdf
- 7. Epilepsy Foundation. Who gets epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Date Accessed 10 November 2020
SOURCE UCB, Inc.
Posted: November 2020
- UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults - October 29, 2008
- UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain - July 29, 2008
- UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy - November 29, 2007
- UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain - November 28, 2007
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