Angelini Pharma’s Cenobamate▼ receives approval in Ireland for use in adults with focal onset seizures in adult patients with epilepsy

• Cenobamate (ONTOZRY®) for adjunctive treatment of focal onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products
• Around 40,000 people in Ireland are currently living with epilepsyⁱ and significant treatment needs remain for those with drug-resistant diseaseⁱⁱ
• 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 activitiesⁱⁱⁱ
• Data show that over half of people taking cenobamate experienced a 50%-or-more reduction in focal (partial) seizure frequency^iv

London, UK, May 15 2023 – Angelini Pharma has today announced that cenobamate, an oral anti-seizure medicine (ASM), has been reimbursed for adjunctive treatment of focal onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.^v  

In Ireland, 30% of people with epilepsy have difficulty controlling their seizures,^vi and are therefore more likely to experience comorbidities, social stigmatisation and have an impaired quality of life.³  

The reimbursement of cenobamate follows the positive recommendation from the National Centre for Pharmacoeconomics (NCPE), and the approval in EU with the European Commission Decision granted on March 26^th, 2021. A pivotal clinical trial data (study C017) published in The Lancet Neurology, also demonstrated that drug-resistant focal-onset seizures showed 50%-or-greater reduction among more than 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 

Professor Norman Delanty, Consultant Neurologist at Beaumont Hospital, Dublin said, “I am very pleased by the HSE’s decision to reimburse the use of cenobamate for eligible people who have epilepsies resistant to current anti-seizure medications. This marks a further important step forward in epilepsy care in Ireland, providing a much needed additional treatment option that has the potential to significantly reduce the frequency of focal-onset seizures.” 

Peter Murphy, CEO at Epilepsy Ireland also commented on today’s announcement saying, “Epilepsy is one of the most common serious neurological conditions in Ireland, and while most people can become seizure-free, as many as 10,000-15,000 people are still living with uncontrolled seizures. For this group in particular, the condition can be a significant long-term, yet often hidden, disability. Living with epilepsy involves learning to cope not only with the physical impact of seizures, but with impaired psychological and social functioning, while stigma is still an issue reported by many. Along with loss of one’s driver’s license or employment, isolation and low self-esteem are all potential challenges that may cause as many problems as the seizures themselves.” He added, “Given the impact that refractory epilepsy can have on all aspects of a person’s life, it's extremely important that patients can access the best possible treatments. It is always encouraging to see the approval of effective new epilepsy medications and cenobamate will offer an additional treatment option for many people in Ireland who have so far struggled to achieve seizure freedom.”  

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 benefits of cenobamate to the people of Ireland”.  

Cenobamate is approved in the EU 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 a history of treatment with at least two anti-epileptic medicinal products.⁷