Posted by Michael Wonder on 27 Mar 2020
Arvelle announces European Medicines Agency acceptance of the marketing authorisation application for cenobamate
26 March 2020 - The applocation seeks authorisation for the adjunctive treatment of focal-onset seizures in adult patients with epilepsy.
Arvelle Therapeutics today announces 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 randomised, 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.
