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Approval provided for Angelini’s cenobamate

Treatment will now be used across Ireland among adults with focal onset seizures with epilepsy.

Angelini Pharma has revealed that cenobamate has been reimbursed for adjunctive treatment of focal onset seizures with or without secondary generalisation among adult patients with epilepsy.

Oral anti-seizure medicine (ASM) concerns individuals who have not been sufficiently controlled in spite of receiving at least two anti-epileptic medicinal products.

The cenobamate verdict follows the positive recommendation from the National Centre for Pharmacoeconomics (NCPE). Pivotal clinical trial data, published in The Lancet Neurology, demonstrated that there was a 50%-or-greater reduction in seizures among more than half of patients when the therapy was added.

Meanwhile, 11.2% of patients were seizure-free when taking 200mg/day of cenobamate, increasing to 21.1% of patients when receiving the maximum daily dose of 400mg/day.

Peter Murphy, chief executive officer at Epilepsy Ireland, reflected: “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 the 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.”

Professor Norman Delanty, a consultant neurologist at Beaumont Hospital, commented: “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.”

Stuart Mulheron, Angelini, UK and Ireland general manager, concluded: “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.”

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

Cenobamate is currently approved, under the same terms, throughout the EU.