NICE recommends Angelini's Ontozry for the treatment of focal-onset seizures

Switzerland-based Arvelle Therapeutics, which was acquired by Italy’s Angelini earlier this year, today announced that it has received a positive Final Appraisal Determination (FAD) from the National Institute for Health and Clinical Excellence (NICE) for Ontozry (cenobamate).

The published 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 antiseizure medicines. It is recommended only if it is used as an add-on treatment, after at least one other add-on treatment has not controlled seizures, and treatment is started in a tertiary epilepsy service.

The NICE FAD recommendation in England and Wales is supported by data from key trials C017 and C021 involving 1,784 patients. The pivotal trial (study C017) published in The Lancet Neurology demonstrated a reduction in focal (partial)-onset seizures frequency 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 100mg dose group, -55.0% (-73.0 to -23.0%; p<0·0001) for the 200mg dose group, and -55.0% (-85.0 to -28.0%; p<0.0001) for the 400mg dose group versus placebo -24.0% (IQR -45.0 to -7.0%). Adverse reactions reported in the C017 study included somnolence, dizziness, headache, fatigue and diplopia.