PARIS– Angelini Pharma, international pharmaceutical company part of the privately held Italian Angelini Group announced today that ONTOZRY® (cenobamate) is now available in the Netherlands for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adults patients who have not been adequately controlled despite an history of treatment with at least two anti-epileptic medicinal products. The product obtained approval from The European Medicines Agency in March’21.
There are an estimated 84 000 people in the Netherlands with epilepsy. Approximately 40% of adult patients with focal epilepsy have inadequate control of seizures after treatment with two anti-seizure medications (ASMs).
Safety and efficacy of this product has been evaluated in three key trials involving over 1,900 patients. The pivotal trial (study 017) published in The Lancet Neurology is a multicenter, double-blind, randomized, placebo-controlled trial has demonstrated that cenobamate at doses of 100 mg, 200 mg, and 400 mg/day significantly improved seizure control versus placebo for adult patients with focal-onset seizures taking 1-3 ASMs.
The product demonstrated significantly higher responder rates (percentage of patients achieving ≥50% reduction in seizures) across all doses during the 12-week maintenance phase compared to placebo. The responder rates were 40% (p=0.036), 56% (p<0.001), and 64% (p<0.001), for the 100 mg, 200 mg, and 400 mg groups, respectively, compared to 25% in the placebo arm. Furthermore, 4% (not significant), 11% (p=0.002), and 21% (p<0.001), of patients treated with this product 100 mg, 200 mg and 400 mg per day, respectively, reported zero focal-onset seizures (100% seizure freedom) compared with only 1% of placebo treated patients during the maintenance phase.
The global disease burden of epilepsy is high. A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life .
In addition, people with epilepsy whose seizures are poorly controlled have higher morbidity and mortality rates, and often experience comorbid illnesses, social stigmatization, and an impaired quality of life.
The product, which was discovered by SK Biopharmaceuticals and SK life science that have partnered with Angelini Pharma for the European market, marks a therapeutic breakthrough in managing the disease, and bringing hope to patients living with epilepsy.
