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EMA accepts Arvelle’s cenobamate MAA

Arvelle Therapeutics’ Marketing Authorisation Application (MAA) for cenobamate has been accepted by the European Medicines Agency (EMA) for the adjunctive treatment of focal-onset seizures in adults with epilepsy.

The company announced that the organisation’s validation of the MAA confirms that the application is complete, and marks the start of the assessment process.

In 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialise cenobamate in Europe.

The authorisation was based on Phase II and III trials, in which the drug showed a statistically significant 56% reduction from baseline in seizure frequency and statistically significant responder rates in all doses.

The acceptance “marks an important milestone for Arvelle” commented Mark Altmeyer, president and chief executive officer of Arvelle Therapeutics. “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.”

There are about six million people in Europe with epilepsy, and approximately 40% of adults with focal-onset seizures continue to experience seizures, even after treatment with two anti-epileptic drugs, underscoring the need for new treatment options.

Last November the The US Food and Drug Administration (FDA) also gave the companies’ joint treatment the go-ahead for partial-onset seizures in adults.

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