Ontozry Wins UK Approval as Epilepsy Treatment
Angelini Pharma’s Ontozry (cenobamate) has been authorized in the UK for treating focal-onset seizures in adults with epilepsy who are not adequately controlled with at least two prior therapies.
The approval was supported by two trials in 1,784 patients that assessed three different doses for reducing the frequency of seizures. The median percentage changes were -35.5 percent for the 100 mg-dose group and -55 percent for both the 200 mg and the 400 mg cohort.
The authorization from the UK’s Medicines and Healthcare products Regulatory Agency followed approval by the European Commission for the same indication in March.
Before Ontzory can be offered through the UK’s National Health Service, it must undergo a cost appraisal by the National Institute for Health and Care Excellence.