Arvelle's cenobamate accepted for EMA review

27 March 2020

Switzerland-based CNS disorders specialist Arvelle Therapeutics today announced that the European Medicines Agency 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-center open-label safety study investigating cenobamate as an adjunctive therapy in adult patients with focal-onset seizures.

Product acquired from SK Biopharma

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