Arvelle Therapeutics’ antiepileptic drug is a step closer to market entry

Arvelle Therapeutics, an emerging biopharmaceutical company, is focused on bringing innovative treatments to patients suffering from CNS disorders. Arvelle is developing cenobamate, an investigational antiepileptic drug for the adjunctive treatment of focal-onset seizures in adults with epilepsy.

The startup has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for cenobamate in the European market. 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.

Arvelle licensed the exclusive rights to develop and commercialise cenobamate in Europe from SK Biopharmaceuticals Co., Ltd. and the data supporting the MAA was generated from SK Life Science’s global clinical trial program. In November 2019, SK life science – which is also a subsidiary of SK Biopharmaceuticals – received approval from the U.S. Food and Drug Administration (FDA) for cenobamate tablets as a treatment for focal-onset seizures. The durg will be commercially available in the U.S. under the trademark XCOPRI.

Commenting on the news, Mark Altmeyer, President and CEO of Arvelle Therapeutics, 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 patients with epilepsy who are still experiencing uncontrolled seizures. We will continue to work in close collaboration with the EMA to progress this application and bring cenobamate to patients across Europe as soon as possible.”

The largest financing round in the industry
In the same year of its founding (2019), Arvelle closed a $207.5 million financing round, one of the largest initial financing commitments for a European-focused biopharmaceutical company. The investment came with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments.

(Press relese / RAN)