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PANGYO, GYEONGGI PROVINCE, Korea, Jan. 29, 2021 /PRNewswire/
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-ons