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Arvelle Announces European Medicines Agency Acceptance of the Marketing Authorization Application for CenobamateArvelle Announces European Medicines Agency Acceptance of the Marketing Authorization Application (MAA) for Cenobamate Zug, Switzerland, 26 March 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy. Validation of the MAA confirms that the application is complete and marks the start of the assessment process. The MAA is supported by data from two randomized, double-blind, placebo-controlled studies, and a large, international, multi-centre open-label safety study investigating cenobamate as an adjunctive therapy in adult patients with focal-onset seizures. Arvelle Therapeutics licensed the exclusive rights to develop and commercialize cenobamate in Europe from SK Biopharmaceuticals Co., Ltd. and the data supporting the MAA was generated from SK Life Science, Inc.’s (a subsidiary of SK Biopharmaceuticals) global clinical trial program. In November 2019, SK life science received approval from the U.S. Food and Drug Administration (FDA) for cenobamate tablets as a treatment for focal-onset seizures. ENDS For more information please contact: Consilum Strategic Communications (international strategic communications) About Arvelle Therapeutics About Cenobamate Cenobamate is believed to work through a unique, dual, complementary mechanism of action: Enhancing inhibitory currents through positive modulation of GABAA receptors at a non-benzodiazepine binding site, and decreasing excitatory currents by both inhibiting the persistent sodium current and enhancing the inactivated state of voltage-gated sodium channels. Long term data of cenobamate is being further studied in the open-label extensions of the double-blind placebo control trials as well as the open-label safety study in adults with focal-onset seizures. Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753). |