Cenobamate has received a positive CHMP opinion for the adjunctive treatment of focal onset seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic products. The European Commission (EC), which is authorized to approve medicinal products in the European Union, is expected to issue its decision within 67 days of receiving the CHMP opinion.
The overall disease burden of epilepsy is high. A diagnosis of epilepsy can confer significant disability on the individual, including physical, psychological and social problems that could negatively impact self-esteem, family, relationships, leisure time, career prospects and ability to drive. In addition, people with epilepsy whose seizures are poorly controlled have higher morbidity and mortality rates and often experience comorbid illness, social stigma, psychological dysfunction, and reduced quality of life.