SK Biopharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-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 two anti-seizure medications (ASMs). The European Commission (EC), which is authorized to approve medicines in the European Union, is expected to issue its decision within approximately 67 days of receipt of the CHMP opinion. SK Biopharmaceuticals and Arvelle Therapeutics entered into a licensing agreement in 2019 for Arvelle to commercialize SK Biopharmaceuticals' cenobamate in Europe. Cenobamate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset (focal-onset) seizures in adults, and it is commercially available in the U.S. under the brand name XCOPRI (cenobamate tablets) CV. Angelini Pharma, which recently announced a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics, plans to launch cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom), after obtaining final approval from the EC. Cenobamate will be branded as ONTOZRY™ for the European markets. There are an estimated six million people in Europe with epilepsy and approximately 40% of adult patients with focal-onset seizures continue to experience seizures after treatment with two ASMs. The CHMP positive opinion was based on results from a global clinical trial program conducted by SK life science, the U.S. subsidiary of SK Biopharmaceuticals. The clinical trial program includes two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.