ONTOZRY® (cenobamate)▼ receives Marketing Authorisation in Great Britain for the treatment of focal-onset seizures in adults with uncontrolled epilepsy
ONTOZRY® (cenobamate)▼ receives Marketing Authorisation in Great Britain
for the treatment of focal-onset seizures in adults with uncontrolled epilepsy
Marketing authorisation of cenobamate offers a new option for adults with epilepsy whose focal seizures are not adequately controlled with at least two other treatments
London, 15th June 2021 – Angelini Pharma announced today that Arvelle Therapeutics Netherlands has been granted the national marketing authorisation (MA) in Great Britain by the Medicines and Healthcare Products Regulatory Agency (MHRA) for ONTOZRY® (cenobamate) for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic medicinal products.
The final MHRA MA for cenobamate was secured via the reliance procedure (ECRP) following approval by the European Commission (EC) which was received on 26th March 2021. Authorisation in Great Britain brings eligible patients with focal-onset seizures a step closer to accessing cenobamate in England, Scotland and Wales. In Northern Ireland, cenobamate is already approved for use following marketing authorisation received by the European Commission via the Centralised Procedure. Cenobamate is also already authorised in all European Union (EU) Member States plus Iceland, Norway and Liechtenstein.
Final advice on cenobamate from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) are expected to be published later in the year and early 2022 respectively.
“The marketing authorisation of ONTOZRY® (cenobamate) in Great Britain is a welcome development for adults affected by focal-onset seizures and is a step closer to bringing a new option for this patient community and healthcare professionals” commented Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics. “We are committed to facilitating access for eligible patients in Great Britain and are looking ahead to supporting the NICE and SMC appraisal processes in the coming months.”
The MHRA authorisation in Great Britain is supported by data from key trials CO17 and CO21 involving 1,784 patients. , The pivotal trial (study C017) published in The Lancet Neurology demonstrated a reduction in focal (partial)-onset seizure with patients receiving 100mg, 200mg and 400mg of adjunctive cenobamate versus placebo. The median percentage changes in seizure frequency were −35·5% (−62·5 to −15·0%; p=0·0071) for the 100 mg dose group, −55·0% (−73·0 to −23·0%; p<0·0001) for the 200 mg dose group, and −55·0% (−85·0 to −28·0%; p<0·0001) for the 400 mg dose group vs placebo [−24·0% (IQR −45·0 to −7·0%).5 Adverse reactions reported in the C017 study included vertigo, nervous system disorders, dizziness, fatigue, double vision and headaches.
“Evidence from key clinical trials indicate that cenobamate can reduce the occurrence of focal-onset seizures which may lead to a potential new management option for adults with epilepsy who have not been successful in managing their condition with available therapies” commented Emmanuel Streel, Director, Medical Affairs. “Today’s decision by the MHRA means that an additional option to reducing the impact of adult epilepsy in Great Britain may now be possible.”
Cenobamate is authorised in Great Britain for the treatment of focal onset seizures, an epileptic seizure that starts in one side of the brain, for people whose current treatment regimens do not offer sufficient control of the condition.1 In the UK, it is estimated that 1 in 100 people have epilepsy and 87 new cases are diagnosed each day. Adult epilepsy places a substantial burden on the NHS, and leads to 60,000 A&E and 40,000 hospital admissions in England.10
“Adult epilepsy can be a challenging and debilitating condition which creates key challenges for people affected and the health system in Great Britain” commented Professor Charlotte Lawthom, Consultant Neurologist at Aneurin Bevan Health Board. “Despite not being specifically mentioned in the NHS Long Term plan the proportion of adults living and dying with epilepsy is increasing9, meaning it is important that new solutions to better manage the condition become available.”
People with epilepsy are likely to be at risk of physical, psychological and social issues that can impact self-esteem, families, relationships, leisure and working life. ,, Early intervention can help to reduce the risk of irreversible disability and premature death.15
“Today’s marketing authorisation is a welcome development for people living with focal epilepsy. A large proportion of people with focal epilepsy, even today, have uncontrolled seizures and there is a clear need for therapeutic advances and innovation” commented Professor Matthew Walker, Professor of Neurology, UCL Queen Square Institute of Neurology Cenobamate was discovered by SK Biopharmaceuticals and SK Life Science, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset (focal) seizures in adults in 2019 and is commercially available in the U.S under the brand name XCOPRI® (cenobamate tablets).
 Summary of Product Characteristics. Ontozry 25mg film-coated tablets. Available at: https://mhraproducts4853.blob.core.windows.net/docs/1bb200d1e71bc5844a3348b2425a19f0abdfb36c. Accessed June 2021
 European Medicines Agency. ONTOZRY, cenobamate. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ontozry. Accessed June 2021
 Northern Ireland Department of Health. EU Exit - Frequently Asked Questions. Available at: https://www.health-ni.gov.uk/eu-exit-frequently-asked-questions. Accessed June 2021
 European Medicines Agency. Marketing Authorisation. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation. Accessed June 2021
 Krauss GL et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicenter, double-blind, randomized, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Apr;19(4):288-289.
 Sperling MR, Klein P, Aboumatar S, Gelfand M, Halford JJ, Krauss GL, Rosenfeld WE, Vossler DG, Wechsler R, Borchert L, Kamin M. Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study. Epilepsia. 2020 Jun;61(6):1099-1108. doi: 10.1111/epi.16525. Epub 2020 May 12. PMID: 32396252; PMCID: PMC7317552.
 Vossler DG. Remarkably High Efficacy of Cenobamate in Adults With Focal-Onset Seizures: A Double-Blind, Randomized, Placebo-Controlled Trial. Epilepsy Curr. 2020;20(2):85-87. Published 2020 Feb 24. doi:10.1177/1535759720903032
 Focal seizures. Epilepsy Action. Available at: https://www.epilepsy.org.uk/info/seizures/focal-seizures. Accessed June 2020
 Epilepsy Action. Epilepsy facts and terminology. Available at: https://www.epilepsy.org.uk/press/facts#:~:text=Epilepsy%20affects%20around%20one%20in,have%20a%20diagnosis%20of%20epilepsy. Accessed June 2021
 Dickson JM, Jacques R, Reuber M, Hick J, Campbell MJ, Morley R, Grünewald RA (2018). Emergency hospital care for adults with suspected seizures in the NHS in England 2007-2013: a cross-sectional study. BMJ Open 2018;8: e023352
 Morrish P, Duncan S, Cock H (2019). Epilepsy deaths: Learning from health service delivery and trying to reduce risk. Epilepsy Behav 103(Pt B):106473
 NHS UK. NHS Long Term Plan. 2019. Available at https://www.longtermplan.nhs.uk/wp-content/uploads/2019/08/nhs-long-term-plan-version-1.2.pdf. Access date: June 2021
 PHE (2018). Deaths Associated with Neurological Conditions in England 2001 to 2014. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/683998/Deaths_associated_with_neurological_conditions_data_briefing.pdf Access date: June 2021
 Epilepsy: a public health imperative. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.
 Kaiser S, et al. Long-term follow-up of topiramate and lamotrigine: a perspective on quality of life.
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 Engel J. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014;17(Suppl 1): S12–7.