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EMA gives market authorisation application to epilepsy treatment from Arvelle Therapeutics

Published on 30/03/20 at 12:43pm

The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for a cenobamate adjunctive treatment of focal-onset seizures in adults with epilepsy.

This approval was based on data from two randomised placebo controlled studies. It also included a large international open-label safety study.

Mark Altmeyer, President and CEO of Arvelle Therapeutics, commented on the approval and said: “The acceptance of the MAA marks an important milestone for Arvelle. Our filing, together with the FDA’s recent approval of cenobamate in the US, makes us believe that cenobamate could provide an effective treatment option for the many focal-onset seizure patients with epilepsy who are still experiencing uncontrolled seizures.

"We will continue to work in close collaboration with the EMA in order to progress this application and bring cenobamate to patients across Europe as soon as possible.”

Arveille has the exclusive rights to develop and commercialise cenobamate in Europe. It has been licensed by SK Biopharmaceutical,s SK Life Science's parent company, who discovered the anti-epileptic drug, gaining FDA approval in November 2019.

Conor Kavanagh

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