NICE has issued a positive recommendation for Arvelle Therapeutics’ cenobamate (Ontozry), for the treatment of focal-onset seizures in adults with uncontrolled epilepsy in England and Wales.
The Final Appraisal Document (FAD) recommends cenobamate as an option for treating focal onset seizures with or without secondary generalised seizures, in adults with drug-resistant epilepsy that has not been adequately controlled with at least two other antiseizure medicines. Cenobamate is recommended as an add-on treatment, after at least one other add-on treatment has not controlled seizures.
The recommendation is supported by data from key trials C017 and C021, involving 1,784 patients. The pivotal trial (study C017) demonstrated a reduction in focal (partial)-onset seizures frequency, with patients receiving 100mg, 200mg, and 400mg of cenobamate versus placebo. Adverse reactions reported in the study included dizziness, headache, fatigue, and diplopia.
Cenobamate, discovered and developed by SK Biopharmaceuticals and SK life science, was approved by the FDA for the treatment of focal-onset seizures in adults in 2019 and is commercially available in the US under the brand name XCOPRI (cenobamate tablets) CV.
Epilepsy affects over 600,000 people in the UK, which is approximately one in every 100 people. In some cases, epileptic seizures can be fatal, and an estimated 1,000 people die in the UK every year because of the condition.
Stuart Mulheron, General Manager UK & Ireland, Angelini Pharma, commented: “Angelini Pharma is committed to improving seizure control for people living with epilepsy. Today’s positive recommendation for cenobamate by NICE is a testament to the strength of key trial data and offers the prospect of better management for people affected by uncontrolled seizures in the UK. The FAD is a significant milestone for cenobamate and takes us closer towards reimbursement in England and Wales.”