SMC approves Angelini Pharma’s ONTOZRY®▼ (Cenobamate) for restricted use in adults with uncontrolled epilepsy in Scotland

SMC approves Angelini Pharma’s ONTOZRY®▼ (Cenobamate) for restricted use in adults with uncontrolled epilepsy in Scotland

• Around 55,000 people in Scotland are currently living with epilepsy[i] and significant treatment needs remain for those with drug-resistant disease[ii]
• Uncontrolled seizures have a high burden on quality of life and can impact many aspects of daily living, such as driving, going to work and completing everyday activities[iii]
• Data show that over half of people taking cenobamate experienced a 50%-or-more reduction in focal (partial) seizure frequency[iv]

London, UK, 7th February 2022 – Angelini Pharma has today announced that cenobamate, an oral anti-seizure medicine (ASM), is now available for use within NHS Scotland as a treatment for eligible adults with uncontrolled focal epilepsy. The Scottish Medicines Consortium (SMC) has accepted cenobamate for restricted use in adults with drug-resistant epilepsy as a second-line adjunctive ASM, after failure of the first adjunctive ASM.[v]

Across the UK, only 52% of people with epilepsy are seizure-free,[vi] and those with poorly controlled seizures are more likely to experience comorbidities, social stigmatisation and poor quality of life.³

The SMC decision follows the positive National Institute for Health and Clinical Excellence (NICE)  recommendation for cenobamate and is based on pivotal clinical trial data (study C017) published in The Lancet Neurology, demonstrating that drug-resistant focal-onset seizures were reduced by at least 50% in over half of patients when adding cenobamate (200 mg/day) to their daily treatment of 1–3 anti-seizure medications.⁴ Furthermore, 11.2% of patients were seizure-free when taking 200 mg/day of cenobamate and this increased to 21.1% of patients taking the maximum daily dose 400 mg/day (during the 12-week maintenance phase).⁴ The most common adverse reactions reported included somnolence, dizziness, fatigue, vertigo, ataxia and headache.[vii]

Commenting on today’s announcement John Paul Leach, Professor of Clinical Neurology at the University of Glasgow School of Medicine, said, “I welcome today’s decision on the use of cenobamate for some patients with resistant epilepsy. It marks an important step forward in epilepsy care in Scotland, giving physicians a new treatment option to help the one-third of patients who have epilepsies resistant to current anti-seizure medications. Clinical studies have shown that in some patients cenobamate can significantly reduce the frequency of focal-onset seizures offering them the potential for an improved quality of life.”

This is welcome news for people living with uncontrolled epilepsy in Scotland, whose lives are often debilitated by frequent seizures,” added Rona Johnson, Policy and Communications Manager at Epilepsy Scotland. “This decision means that eligible people with epilepsy in Scotland will now have access to a new treatment option that could significantly reduce the frequency of seizures for some, giving them the potential of improved quality of life.”

Stuart Mulheron, Angelini, UK & Ireland General Manager commented, “We are committed to bringing life-changing treatments to people living with epilepsy and are delighted to be able to bring the potential benefits of cenobamate to people in Scotland.”

Cenobamate has received marketing authorisation in Great Britain and authorised in the EU for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.⁷

[i] Epilepsy Scotland. Available at: https://www.epilepsyscotland.org.uk/ Last accessed: February 2022.

[ii] Schmidt D et al. BMJ. 2014;348:g2546.

[iii] National Institute for Health and Care Excellence. NICE Technical Appraisal Guidance [TA753]. Available at: https://www.nice.org.uk/guidance/ta753/chapter/3-Committee-discussion Accessed February 2022.

[iv] Krauss L G et al. Lancet Neurol. 2020 Jan;19(1):38-48.

[v] Scottish Medicines Consortium. Cenobamate. Available at: https://www.scottishmedicines.org.uk/medicines-advice/cenobamate-ontozry-full-smc2408/ Accessed February 2022.

[vi] Epilepsy Action. Epilepsy facts and terminology. Available at: https://www.epilepsy.org.uk/press/facts Accessed February 2022.

[vii] Cenobamate Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/13012/smpc#gref Accessed February 2022.

[viii] Epilepsy Scotland https://www.epilepsyscotland.org.uk/about-epilepsy/epilepsy-and-seizures-explained/ Accessed February 2022.

[ix] FDA. Cenobamate prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf Accessed February 2022.

[x] Guignet M et al. Epilepsia. 2020 Oct 16. doi: 10.1111/epi.16718.

[xi] Sharma R et al. Eur J Pharmacol. 2020;879:173117.

[xii] Nakamura M, et al. Eur J Pharmacol. 2019;855:175-182.

[xiii] Anderson LL et al. Epilepsia. 2014;55(8):1274-1283.

[xiv] Sperling MR, et al. Epilepsia. Feb 2020;61:1099–1108.

[xv] Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures NCT03678753.